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Point-of-Care Diagnostics 2011 Players, Products and Future Market

Prospects

May 2011

Point-of-Care Diagnostics 2011 - Players, Products and Future Market Prospects

May 2011

ISBN: 978 1 85822 422 0

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©Espicom Business Intelligence May 2011ii

Table of Contents

ContentsEXECUTIVE SUMMARY .......................................................................................................................................1

BACKGROUND ..................................................................................................................................................................................2The Role Of POC Testing .............................................................................................................................................................. 3

CURRENT MARKET DYNAMICS ......................................................................................................................................................5Fig.1: POC Diagnostics in Relation to the IVD Market, 2010 ............................................................................................................................................................................5Global POC Diagnostics Market by Product Type, 2007-2010 (US$ million) ...................................................................................................................................................6Fig.2: Percentage of POC Diagnostics Market by Product, 2010 ......................................................................................................................................................................7Fig.3: POC Diagnostics Market by Product, excl. Glucose, 2010 .......................................................................................................................................................................7

Customers of POC Diagnostic Products ..................................................................................................................................... 8POC Technologies by Customer Segment ........................................................................................................................................................................................................9Fig.4: POC Diagnostics Market by Customer Type, 2010 ..................................................................................................................................................................................9Fig.5: POC Diagnostics Self-Testing Market by Product Type, 2010 ...............................................................................................................................................................10

Regional Perspective ................................................................................................................................................................ 10Fig.6: POC Diagnostics Market by Region, 2010 ............................................................................................................................................................................................11Fig.7: Professional POC Diagnostics Market by Region, 2010 .......................................................................................................................................................................11

Regulatory and Reimbursement Environment ...................................................................................................................... 12CLIA Waiver ............................................................................................................................................................................................... 12

COMPETITIVE LANDSCAPE ...........................................................................................................................................................14Market Leaders by POC Product Type ............................................................................................................................................................................................................14Key POC Diagnostics Mergers and Acquisitions, 2008-2010 .........................................................................................................................................................................15

GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES ..........................................................................................17Clinical Utility and Accuracy ..................................................................................................................................................... 17POC Diagnostics as a Disruptive Technology .......................................................................................................................... 18Connectivity ............................................................................................................................................................................... 18Future Technology: Next-Generation POC Diagnostic Products .......................................................................................... 19

Summary: Market Drivers, Restraints and Opportunities ............................................................................................................................................................................20MARKET OUTLOOK ........................................................................................................................................................................21

Global POC Diagnostics Market by Product Type, 2007-2016E (US$ million) ................................................................................................................................................22Fig.9: POC Diagnostics Market by Product, excl. Glucose, 2016E ...................................................................................................................................................................23

POC PRODUCTS AND TECHNOLOGIES ...........................................................................................................24BLOOD GLUCOSE TESTING AND DIABETES ................................................................................................................................24

WHO Diabetes Prevalence, 2000 and 2030 ..................................................................................................................................................................................................25Blood Glucose Testing Market Dynamics ................................................................................................................................25

Fig.10: Global Blood Glucose Testing Market, 2005-2016E (US$ billion) .......................................................................................................................................................26Fig.11: Blood Glucose Testing Market by Customer Type, 2010......................................................................................................................................................................26Leading Companies’ Diabetes Care Sales, 2004-2010 (US$ million) .............................................................................................................................................................27

Diabetes Self-Testing ................................................................................................................................................................27Conventional Blood Glucose Testing Products and Technologies ........................................................................................28

Market-Leading Self-Testing Blood Glucose Meters......................................................................................................................................................................................29Abbott’s Test Strip Product Recall ........................................................................................................................................................29Competing Self-Testing Blood Glucose Meters ..............................................................................................................................................................................................29FDA Warning - GDH-PQQ Test Strips ....................................................................................................................................................30New Products ..........................................................................................................................................................................................31

77 Electronica’s AutoSense .................................................................................................................................................................................................................31Abbott’s FreeStyle Lite and FreeStyle Freedom Lite Test Strips ........................................................................................................................................................31ACON Laboratories’ On Call Blood Glucose Monitoring Systems ......................................................................................................................................................32AgaMatrix’ WaveSense Products .......................................................................................................................................................................................................32Arkray’s Glucocard Blood Glucose Monitoring Systems ....................................................................................................................................................................32Bayer’s Contour USB ............................................................................................................................................................................................................................33Bayer’s DIDGET Meter .........................................................................................................................................................................................................................33Cambridge Sensors’ Microdot+ .........................................................................................................................................................................................................33Infopia’s Blood Glucose Products .......................................................................................................................................................................................................34

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LifeScan’s New OneTouch Products ...................................................................................................................................................................................................34Nova Biomedical’s Nova Max Plus ..................................................................................................................................................................................................... 35Roche’s Accu-Chek Products ............................................................................................................................................................................................................. 35sanofi-aventis/AgaMatrix BGStar and iBGStar ................................................................................................................................................................................. 36Standard Diagnostics’ SD Check Gold and SD Codefree/SmartLink Gold ........................................................................................................................................ 36

Professional Use Products ................................................................................................................................................................... 36Abbott’s Precision XceedPro Blood Glucose and ß-Ketone Monitoring System ............................................................................................................................. 36AgaMatrix’ KeyNote Pro ....................................................................................................................................................................................................................36Arkray Assure Blood Glucose Testing Products ................................................................................................................................................................................. 37Bayer’s Hospital Blood Glucose Monitoring Products ...................................................................................................................................................................... 37EKF Diagnostics’ Biosen C ..................................................................................................................................................................................................................38LifeScan’s SureStep Flexx and SureStep Hospital ............................................................................................................................................................................38Nova Biomedical’s StatStrip Glucose Monitor ...................................................................................................................................................................................38Quest Diagnostics’ HemoCue Blood Glucose Testing Systems ......................................................................................................................................................... 39Roche’s Accu-Chek Inform II ............................................................................................................................................................................................................. 39

Continuous Glucose Monitoring ..............................................................................................................................................39Clinical Trial Results - Highlighting Benefits and Drawbacks ......................................................................................................... 40Reimbursement Issues .......................................................................................................................................................................... 40CGM Competitive Landscape ................................................................................................................................................................41Medtronic’s CGM Systems .....................................................................................................................................................................41

Paradigm Veo .................................................................................................................................................................................................................................... 42Paradigm REAL-Time Revel ............................................................................................................................................................................................................... 42Guardian REAL-Time System ............................................................................................................................................................................................................. 43iPro Professional Use Products .......................................................................................................................................................................................................... 43CareLink Pro 3.0 Therapy Management Software ........................................................................................................................................................................... 43Clinical Trials .......................................................................................................................................................................................................................................44

DexCom’s CGM Systems ........................................................................................................................................................................ 45FDA Warning Letter ........................................................................................................................................................................................................................... 45

Abbott’s FreeStyle Navigator CGM System ....................................................................................................................................... 46A Menarini Diagnostics’ GlucoDay S ................................................................................................................................................... 46CGM Products in Development ........................................................................................................................................................... 46

DexCom Products ..............................................................................................................................................................................................................................46Medtronic ........................................................................................................................................................................................................................................... 47Sensors for Medicine & Science’s SMSI Glucose Sensor .................................................................................................................................................................... 47Via Medical’s Via Blood Glucose Monitoring System ....................................................................................................................................................................... 47

Next-Generation Blood Glucose Testing ............................................................................................................................... 48AiMedics’ HypoMon .............................................................................................................................................................................. 48Echo Therapeutics’ Symphony tCGM System ................................................................................................................................... 48

Clinical Study Results ......................................................................................................................................................................................................................... 49GluMetrics’ GluCath IV-CGM ................................................................................................................................................................ 50Integrity Applications’ GlucoTrack ...................................................................................................................................................... 50Lein Applied Diagnostics .......................................................................................................................................................................51Medtronic .................................................................................................................................................................................................52MicroCHIPS ...............................................................................................................................................................................................52Pepex Biomedical’s Trio Products ........................................................................................................................................................52OrSense’s NBM-200G Non-Invasive Blood Glucose Meter ..............................................................................................................53Solianis Monitoring’s Multisensor Glucose Monitoring System .....................................................................................................53VeraLight’s SCOUT DS ........................................................................................................................................................................... 54

HbA1c Testing.............................................................................................................................................................................54HbA1c Products........................................................................................................................................................................................55

ApexBio’s A1C Express ........................................................................................................................................................................................................................ 55Axis-Shield’s Afinion HbA1c and NycoCard HbA1c Tests ................................................................................................................................................................... 55Bayer’s A1CNow Products ..................................................................................................................................................................................................................56Bio-Rad’s in2it A1C Analyser .............................................................................................................................................................................................................56DiaSys Diagnostic Systems’ InnovaStar .............................................................................................................................................................................................56

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Ceragem Medisys’ LabonaCare HbA1c .............................................................................................................................................................................................56Infopia’s Easy/Clover A1c ....................................................................................................................................................................................................................56Quotient Diagnostics’ Quo-Test .........................................................................................................................................................................................................56Siemens’ DCA Vantage Analyser ....................................................................................................................................................................................................... 57In Development .................................................................................................................................................................................................................................57

Ketone Testing ...........................................................................................................................................................................57POC CARDIOVASCULAR TESTING ............................................................................................................................................... 59

POC Coagulation Testing ..........................................................................................................................................................59Market Dynamics ................................................................................................................................................................................... 60Fig.12: Global POC Coagulation Market, 2007-2016E (US$ million) .............................................................................................................................................................60Self-Monitoring Products ......................................................................................................................................................................61

CoaguSense’s CoaguSense PT/INR Monitoring System .................................................................................................................................................................... 62Alere’s INRatio2 System .................................................................................................................................................................................................................... 62Nexus Dx’s ProTime Systems ............................................................................................................................................................................................................. 62Roche’s CoaguChek XS ......................................................................................................................................................................................................................62

Professional Use Products .................................................................................................................................................................... 63Axis-Shield Products ..........................................................................................................................................................................................................................63Helena Laboratories’ Cascade POC System ....................................................................................................................................................................................... 63Helena Laboratories’ Actalyke & MAX-ACT ......................................................................................................................................................................................64Medtronic‘s ACT Plus Automated Coagulation Timer System .........................................................................................................................................................64Instrumentation Laboratory’s GEM PCL Plus ....................................................................................................................................................................................64Nexus Dx’s Hemochron Whole Blood Coagulation System ..............................................................................................................................................................64Roche’s CoaguChek Systems..............................................................................................................................................................................................................65

In Development - Bio-AMD’s COAG ................................................................................................................................................... 66Platelet Function and Antiplatelet Drug Assessment ............................................................................................................66

Clopidogrel Effectiveness Assessment ...............................................................................................................................................67Spartan Bioscience’s Spartan RX CYP2C19 POC DNA Testing System .............................................................................................................................................. 67

Accumetrics’ VerifyNow System .......................................................................................................................................................... 68Clinical Trials .......................................................................................................................................................................................................................................68

Helena Laboratories’ Plateletworks System ..................................................................................................................................... 69Cardiac Markers .........................................................................................................................................................................69

POC Testing ..............................................................................................................................................................................................70Fig.13: Global POC Cardiac Marker Testing Market, 2007-2016E (US$ million) ............................................................................................................................................72POC Testing Products ............................................................................................................................................................................ 72Currently-Available Cardiac Marker POC Tests .............................................................................................................................................................................................72

Alere’s Heart Check System ...............................................................................................................................................................................................................73Alere’s Triage and Clearview Products ..............................................................................................................................................................................................73bioMérieux VIDAS Emergency Care Products ................................................................................................................................................................................... 74Nexus Dx’s POC Cardiovascular Tests ................................................................................................................................................................................................. 74Princeton BioMeditech/LifeSign’s StatusFirst Tests and DXpress Reader ........................................................................................................................................ 74Mitsubishi Chemical’s Pathfast Immunoassay Analyzer .................................................................................................................................................................. 75Response Biomedical’s RAMP 200 Platform ..................................................................................................................................................................................... 75Randox Laboratories’ Evidence Multistat ......................................................................................................................................................................................... 76Roche Cardiac Testing Products ........................................................................................................................................................................................................ 76Siemens’ Stratus CS Analyzer ............................................................................................................................................................................................................ 76Products in Development ..................................................................................................................................................................................................................77

Cholesterol Testing....................................................................................................................................................................78Fig.14: Global POC Cholesterol Testing Market, 2007-2016E (US$ million) .................................................................................................................................................. 79Home Testing .......................................................................................................................................................................................... 79

Alere’s First Check Cholesterol Test ................................................................................................................................................................................................... 79Akers Biosciences’ Tri-Cholesterol Check ......................................................................................................................................................................................... 79Chematics Chemcard Cholesterol Test .............................................................................................................................................................................................. 79Infopia’s Lipid Pro ...............................................................................................................................................................................................................................80Roche’s Accutrend Plus .....................................................................................................................................................................................................................80Syntron Bioresearch’s Venture Total Cholesterol Test ......................................................................................................................................................................80

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Professional Use Products .................................................................................................................................................................... 80Alere’s Cholestech LDX System .........................................................................................................................................................................................................80Jant Pharmacal’s LipidPlus Lipid Profile and Glucose Test System ..................................................................................................................................................80Polymer Technology Systems’ CardioChek .......................................................................................................................................................................................80Miraculins’ PREVU Point of Care Skin Sterol Test .............................................................................................................................................................................. 81

MULTI-FUNCTIONAL CLINICAL CHEMISTRY ANALYSERS ....................................................................................................... 83Abaxis’ Piccolo xpress ...............................................................................................................................................................83Abbott’s i-STAT System ............................................................................................................................................................ 84Alfa Wassermann’s ACE Clinical Chemistry Systems ..............................................................................................................85Audit Diagnostics’ Liqui-Stat Wet Chemistry POC System ....................................................................................................85Arkray’s SpotChem EZ Dry Chemistry .....................................................................................................................................85Axis-Shield’s Afinion POC System ............................................................................................................................................86Axis-Shield’s NycoCard System ................................................................................................................................................87Horiba ABX’ ABX Pentra 400 Clinical Chemistry Analyser .....................................................................................................87MagnaBioSciences’ MICT ..........................................................................................................................................................87Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System .............................................................................................88OrSense’s NBM Products ...........................................................................................................................................................88

NBM-200MP Oximetry .......................................................................................................................................................................... 88NBM 200 Haemoglobin ......................................................................................................................................................................... 89

Probe Scientific MicroEye Blood Analysis Device ...................................................................................................................90Radiometer’s AQT90 FLEX Immunoassay Analyser ................................................................................................................90Randox Laboratories’ Evidence Multistat ...............................................................................................................................91ReLIA Diagnostic Systems’ ReLIA System ................................................................................................................................91Tosoh Bioscience’s AIA-360 Immunoassay Analyser ..............................................................................................................92

In Development ......................................................................................................................................................................................92Ativa Medical’s POC Analyser............................................................................................................................................................................................................. 92Atonomics’ Atolyzer ........................................................................................................................................................................................................................... 93Claros Diagnostics’ Claros System ..................................................................................................................................................................................................... 93pes diagnosesysteme’ respons IQ .....................................................................................................................................................................................................94Infopia’s Tele-Diagnostic System .......................................................................................................................................................................................................94

POC BLOOD GAS/ELECTROLYTE ANALYSERS ........................................................................................................................... 95Mayo Clinic’s Estimated Glomerular Filtration Rate Study....................................................................................................95Arkray’s SpotChem EL Electrolyte Analyser ............................................................................................................................96Epocal’s epoc ..............................................................................................................................................................................96Instrumentation Laboratory’s GEM Premier Products .........................................................................................................97

tBili Assay ................................................................................................................................................................................................. 97GEMweb Plus Custom Connectivity.................................................................................................................................................... 97

Nexus Dx’s IRMA TRUpoint Blood Analysis System ................................................................................................................98Nexus Dx’s AVOXimeter Products ............................................................................................................................................98Nova Biomedical’s Products .....................................................................................................................................................98

Stat Profile Critical Care Xpress ........................................................................................................................................................... 98Stat Profile pHOx ...............................................................................................................................................................................................................................98

Nova Biomedical Electrolyte/Chemistry Analysers ......................................................................................................................... 99Statsensor Creatinine Meter ................................................................................................................................................................ 99StatStrip Lactate ..................................................................................................................................................................................... 99

OPTI Medical Systems’ Products ........................................................................................................................................... 100Radiometer’s Blood Gas Analysers ....................................................................................................................................... 100

1st automatic ......................................................................................................................................................................................... 100ABL80 FLEX ............................................................................................................................................................................................ 100ABL90 FLEX ........................................................................................................................................................................................... 101ABL800 FLEX.......................................................................................................................................................................................... 101ABL5 ........................................................................................................................................................................................................ 101ABL80 FLEX CO-OX CO Oximeter ...................................................................................................................................................... 101

Roche’s cobas Blood Gas Analysers .......................................................................................................................................102Siemens’ Blood Gas Analyser Range .....................................................................................................................................102

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RAPIDLab Analysers............................................................................................................................................................................. 102RAPIDPoint Blood Gas Systems ......................................................................................................................................................... 103RAPIDChem 744/754 Electrolyte and Lithium Testing ................................................................................................................. 103RAPIDComm Data Management and Connectivity Solution ...................................................................................................... 103Via Medical’s Products......................................................................................................................................................................... 104

POC HAEMATOLOGY AND HAEMOSTASIS PRODUCTS ......................................................................................................... 105Surgical Coagulation and Haemostasis Management.........................................................................................................105

Akers Biosciences’ PIFA Heparin/PF4 Rapid Assay ......................................................................................................................... 105PIFA HPF4 POC ..................................................................................................................................................................................................................................106

Haemonetics’ TEG Thrombelastograph Hemostasis Analyzer .................................................................................................... 106Instrumentation Laboratory’s GEM PCL Plus .................................................................................................................................................................................106

Medtronic’s HMS PLUS Haemostasis Management System ........................................................................................................ 107Pentapharm’s ROTEM delta ................................................................................................................................................................ 107Sienco’s Sonoclot Coagulation & Platelet Function Analyzers .................................................................................................... 107

Haematology Analysers ..........................................................................................................................................................108Beckman Coulter’s COULTER AC•T Series ........................................................................................................................................ 108Quest Diagnostics’ HemoCue White Blood Cell Analyzer ............................................................................................................ 108Horiba ABX’ Haematology Analysers ............................................................................................................................................... 108

ABX Micros ES60...............................................................................................................................................................................................................................108ABX Micros 60 ...................................................................................................................................................................................................................................109ABX Micros CRP 200 .........................................................................................................................................................................................................................109ABX E-Sat ..........................................................................................................................................................................................................................................109ABX Pentra 60C+ .............................................................................................................................................................................................................................109

Symex’ pocH-100i Haematology Analyser ...................................................................................................................................... 109Arkray’s PocketChem BA Blood Ammonia Meters ...............................................................................................................110Haemoglobin Systems ............................................................................................................................................................110

ACON Laboratories’ Mission Hb Hemoglobin Testing System......................................................................................................110ApexBio’s HemoSmart Haemoglobin Screening System ..............................................................................................................110Audit Diagnostics’ Hb-Stat ..................................................................................................................................................................110EKF Diagnostics’ Hemo-Control and Hemo Speed Products ........................................................................................................110Instrumentation Laboratory’s IL 682 CO-Oximeter ........................................................................................................................111Nexus Dx’s Hgb Pro Professional Hemoglobin Testing System....................................................................................................111Quest Diagnostics’ HemoCue Haemoglobin Systems ...................................................................................................................111

HemoCue 201 DM Analyser Whole Blood Systems .........................................................................................................................................................................111Stanbio Laboratory’s HemoPoint H2 and STAT-Site M Hgb ..........................................................................................................112URIT Medical’s URIT-12 Hemoglobin Meter ......................................................................................................................................112

POC INFECTIOUS DISEASE TESTS ..............................................................................................................................................113Fig.15: Global POC Infectious Disease Testing Market, 2007-2016E (US$ million) ...................................................................................................................................... 114

POC Influenza Testing .............................................................................................................................................................114Performance and Use of Rapid Influenza Tests in the US ..............................................................................................................114Flu Detection Products .........................................................................................................................................................................115

3M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay ...................................................................................................................................................... 116Alere’s BinaxNOW Influenza A&B Test ............................................................................................................................................................................................ 116Alere’s Clearview Exact Influenza A & B .......................................................................................................................................................................................... 116Becton Dickinson’s Directigen EZ Flu A+B test ............................................................................................................................................................................... 116Jant Pharmacal’s Accutest Flu Test .................................................................................................................................................................................................. 116Medix Biochemica’s Actim Influenza A&B ...................................................................................................................................................................................... 116Meridian Bioscience’s TRU FLU .........................................................................................................................................................................................................117Mizuho Medy’s Quick Chaser Flu A,B ................................................................................................................................................................................................117OraSure Technologies’ OraSure QuickFlu Rapid Flu A+B Test .........................................................................................................................................................117Princeton BioMeditech’s BioSign Flu A+B ......................................................................................................................................................................................117Quidel’s QuickVue Influenza Tests ....................................................................................................................................................................................................117Remel’s Xpect Flu A&B ......................................................................................................................................................................................................................117SA Scientific’s SAS FluAlert .............................................................................................................................................................................................................. 118Sekisui Diagnostics’ OSOM Influenza A & B Test ............................................................................................................................................................................. 118

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Sysmex’ POCTEM Influenza A/B ...................................................................................................................................................................................................... 118Products in Development ....................................................................................................................................................................118

Chembio’s DPP Influenza Tests ........................................................................................................................................................................................................ 118Enigma Diagnostics’ Enigma ML Influenza A/B Detection Assay ................................................................................................................................................. 118IQuum’s Liat System ..........................................................................................................................................................................................................................119Nexus Dx’s Rapid Flu Tests ................................................................................................................................................................................................................119

Respiratory Syncytial Virus ....................................................................................................................................................1203M’s 3M Rapid Detection RSV Test .....................................................................................................................................................121Quidel’s QuickVue RSV 10 ....................................................................................................................................................................121

Other Respiratory Tests ..........................................................................................................................................................121Ani Biotech’s Biocard Chlamydia Pneumoniae IgM Test ................................................................................................................121GenBio’s ImmunoFLOW Mycoplasma IgM Test ...............................................................................................................................121In Development - Tyrian Diagnostics’ DiagnostIQ ........................................................................................................................ 122

POC HIV Testing .......................................................................................................................................................................122HIV Prevalence by Region, 2001 and 2009 ................................................................................................................................................................................................ 123Market Dynamics ..................................................................................................................................................................................124Product Highlights ................................................................................................................................................................................124

Alere’s Pima Point-of-Care CD4 Analyser ....................................................................................................................................................................................... 124Alere’s SD, Determine and Clearview HIV Tests .............................................................................................................................................................................. 125bioLytical Laboratories’ INSTI Kit ..................................................................................................................................................................................................... 125bioMérieux’s VIKIA HIV 1/2 HIV Test ................................................................................................................................................................................................ 125Bio-Rad’s Multispot HIV-1/HIV-2 Rapid Test ................................................................................................................................................................................... 126Calypte Biomedical’s Aware HIV-1/2 Tests ...................................................................................................................................................................................... 126Chembio Diagnostics’ Sure Check (Clearview Complete), STAT PAK (Clearview HIV 1/2 STAT-PAK) and HIV 1/2 STAT PAK DIPSTICK ......................................... 126

Chembio Diagnostics’ Dual Path Platform Technology Products ...............................................................................................127EY Laboratories’ InstantCHEK .......................................................................................................................................................................................................... 128Hema Diagnostic Systems ............................................................................................................................................................................................................... 128IND Diagnostic’s One-Step Anti-HIV (1+2) Tests ............................................................................................................................................................................. 128Lab21’s Biotec Tests .......................................................................................................................................................................................................................... 129MedMira’s Tests................................................................................................................................................................................................................................ 129Integrated Medical Innovations’ FirstVue HIV Tests ....................................................................................................................................................................... 130OraSure’s OraQuick ADVANCE HIV-1/2 ............................................................................................................................................................................................ 130Trinity Biotech’s POC HIV Tests ......................................................................................................................................................................................................... 130Savyon Diagnostics’ HIVSav 1/2/0 Rapid SeroTest ......................................................................................................................................................................... 131Unimed’s FirstSign HIV Duo ............................................................................................................................................................................................................. 131YD Diagnostics’ AIDScan .................................................................................................................................................................................................................. 131

Products in Development ....................................................................................................................................................................131Alere’s HIV NAT System .................................................................................................................................................................................................................... 131Calypte Biomedical’s Aware II (The Ani Platform) .......................................................................................................................................................................... 131Cepheid’s GeneXpert System and Xpert HIV Viral Load Test .......................................................................................................................................................... 132Daktari Diagnostics’ Daktari CD4 ..................................................................................................................................................................................................... 132IQuum’s Liat System ......................................................................................................................................................................................................................... 132OraSure’s OraQuick HIV OTC Test ..................................................................................................................................................................................................... 133

POC Hepatitis Tests..................................................................................................................................................................133Hepatitis B ..............................................................................................................................................................................................133Hepatitis C .............................................................................................................................................................................................. 134Available Tests ...................................................................................................................................................................................... 134

Alfa Scientific Designs’ Instant-View Tests ..................................................................................................................................................................................... 134bioMérieux‘ VIKIA HBs Ag Test ........................................................................................................................................................................................................ 135Integrated Medical Innovations’ FirstVue Rapid Test Kit ............................................................................................................................................................... 135OraSure Technologies’ OraQuick HCV Rapid Antibody Test ........................................................................................................................................................... 135Runbio Biotech’s One Step Tests ...................................................................................................................................................................................................... 136YD Diagnostics’ HepaScan Tests ..................................................................................................................................................................................................... 136

In Development .................................................................................................................................................................................... 136Chembio’s DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests ........................................................................................................................... 136

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Exalenz Bioscience’s BreathID System ............................................................................................................................................................................................ 137MedMira’s Multiplo Combination HIV/Hepatitis Tests ........................................................................................................137POC Tuberculosis Tests ............................................................................................................................................................138

Cepheid’s Xpert MTB/RIF .................................................................................................................................................................... 139In Development .................................................................................................................................................................................... 139

Chembio’s DPP Tuberculosis ........................................................................................................................................................................................................... 139TwistDx’s Recombinase Polymerase Amplification Technology ....................................................................................................................................................140

Tropical Disease Tests..............................................................................................................................................................140Hema Diagnostic Systems’ Malaria Tests ......................................................................................................................................... 140Lab21’s Tropical Disease Tests ............................................................................................................................................................ 140Quest Diagnostics’ Focus Dengue Rapid Tests ................................................................................................................................141New Horizons Diagnostics’ Cholera and Bengal SMART ...............................................................................................................141Unimed’s FirstSign Typhoid Tandem Test.........................................................................................................................................141Products in Development ....................................................................................................................................................................141

Chembio’s DPP Leptospirosis .......................................................................................................................................................................................................... 141Chembio’s DPP Visceral Leishmaniasis ............................................................................................................................................................................................ 142

Sexually-Transmitted Diseases and Related Diagnostics ....................................................................................................142Ani Biotech’s Biocard Candida and Trichomonas Tests ................................................................................................................. 142Focus Diagnostics’ HerpeSelect Express HSV-2 .............................................................................................................................. 142Gryphus Diagnostics’ BVBLUE ........................................................................................................................................................... 143Hema Diagnostic Systems’ Rapid 1-2-3 Hema Syphilis ................................................................................................................. 143MagnaBioSciences MICT Chlamydia Test ........................................................................................................................................ 143Mizuho Medy’s Quick Chaser TP Ab .................................................................................................................................................. 143New Horizons Diagnostics’ GonoGen II and TRUST ....................................................................................................................... 143Quidel’s QuickView Chlamydia Test ................................................................................................................................................. 143RunBio Biotech’s Tests ......................................................................................................................................................................... 143Savyon Diagnostics’ SavvyCheck ...................................................................................................................................................... 144Sekisui Diagnostics’ OSOM Trichomonas ........................................................................................................................................ 144Products In Development .................................................................................................................................................................. 144

Chembio’s DPP Syphilis Tests ...........................................................................................................................................................................................................144Randox Laboratories’ Lab-on-a-Chip ............................................................................................................................................................................................. 145

Trinity Biotech’s Uni-Gold Legionella Urinary Antigen .......................................................................................................145Group A Streptococcus Tests ..................................................................................................................................................145

Currently Available POC Tests ..................................................................................................................................................................................................................... 145H. pylori Tests ...........................................................................................................................................................................146

Currently Available H. pylori Tests ..............................................................................................................................................................................................................146Exalenz Bioscience’s BreathID System ..............................................................................................................................................147Meretek Diagnostics’ BreathTek UBT ............................................................................................................................................... 148

Mononucleosis Tests ...............................................................................................................................................................148Currently Available POC Tests .....................................................................................................................................................................................................................148

Rotavirus and Adenoviral Enteritis Tests ..............................................................................................................................149Ani Biotech’s Biocard Tests ................................................................................................................................................................. 149Meridian Bioscience ImmunoCard STAT! Rotavirus ....................................................................................................................... 149Orion Diagnostica’s Diarlex, Rotalex and Adenolex Tests ............................................................................................................ 149

POC C-REACTIVE PROTEIN DIAGNOSTICS ............................................................................................................................... 150Abaxis’ MetLyte Plus CRP and BioChemistry Panel Plus ......................................................................................................150Axis-Shield ...............................................................................................................................................................................151Medix Biochemica’s Actim CRP ..............................................................................................................................................151Orion Diagnostica’s QuikRead and QuikRead go Systems ..................................................................................................151In Development .......................................................................................................................................................................151

LifeAssays’ CRP ......................................................................................................................................................................................151POC CANCER DIAGNOSTICS ...................................................................................................................................................... 152

Fig.16: Global POC Cancer Markers Market, 2007-2016E (US$ million)...................................................................................................................................................... 152Prostate Specific Antigen Tests ..............................................................................................................................................153

Available Tests ...................................................................................................................................................................................... 154

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Claros Diagnostics’ Claros System ................................................................................................................................................................................................... 154Mediwatch’s PSAwatch ................................................................................................................................................................................................................... 155

Occult Blood Testing ...............................................................................................................................................................155ACON Laboratories’ Mission FOB Reagent Strips .......................................................................................................................... 156Aerscher Diagnostics’ HemaPrompt ................................................................................................................................................ 156Alere’s Tests ........................................................................................................................................................................................... 156Beckman Coulter’s Hemoccult Tests ................................................................................................................................................ 156Biomerica’s EZ Detect .......................................................................................................................................................................... 156Helena Laboratories’ ColoCare .......................................................................................................................................................... 156Immunostics’ Hema-Screen ............................................................................................................................................................... 157Orion Diagnostica’s QuikRead System and Orion Q-flow FOB .................................................................................................... 157Princeton BioMeditech’s BioSign iFOBTest ..................................................................................................................................... 157Quest Diagnostics’ InSure Quik F I T ................................................................................................................................................. 157Quidel’s QuickVue iFOB ...................................................................................................................................................................... 158Other Available FOB Tests .................................................................................................................................................................. 158Gastric Occult Blood Tests ................................................................................................................................................................... 159

CEA Testing ...............................................................................................................................................................................159Alpha Fetoprotein Testing ......................................................................................................................................................160Bladder Cancer Testing ...........................................................................................................................................................160

Alere’s Matritech NMP22 BladderChek Test .................................................................................................................................... 160Mediwatch’s Bladderwatch BTA Test ................................................................................................................................................ 160

Novel Products in Development ............................................................................................................................................160Akers Biosciences’ BreathPulmo Health “Check” ........................................................................................................................... 160Balter Medical’s Optical Transfer Diagnosis Platform ....................................................................................................................161Guided Therapeutics’ LightTouch Cervical Cancer Scanner..........................................................................................................161

Lung and Oesophageal Cancer ........................................................................................................................................................................................................ 162Infopia’s Cancer Diagnosing Sensor ................................................................................................................................................. 163

URINALYSIS ..................................................................................................................................................................................164Fig.17: Global POC Urinalysis Market, 2007-2016E (US$ million) ...............................................................................................................................................................164Product Highlights - Urine Analysis Test Strips........................................................................................................................................................................................... 165

Key Products ............................................................................................................................................................................165ACON Laboratories’ Mission Products .............................................................................................................................................. 165Arkray’s Products ................................................................................................................................................................................. 166

PocketChem UA ................................................................................................................................................................................................................................166AUTION ELEVEN ................................................................................................................................................................................................................................166DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips .......................................................................................................................................166Diagnostic Test Group’s Clarity Urocheck 120 Analyzer .................................................................................................................................................................166

Roche’s Products .................................................................................................................................................................................. 166Urisys 1100 Urine Analyser ..............................................................................................................................................................................................................166Chemstrip Criterion II Analyzer........................................................................................................................................................................................................166

Siemens’ Products ................................................................................................................................................................................ 167Clinitek Advantus Analyser .............................................................................................................................................................................................................. 167Clinitek Status Analyser ................................................................................................................................................................................................................... 167Clinitek Status+ ............................................................................................................................................................................................................................... 167Clinitek Status Connect .................................................................................................................................................................................................................... 167RAPIDComm Data Management and Connectivity Solution ......................................................................................................................................................... 167

New Products ..........................................................................................................................................................................16877 Elektronika’s DocUReader 2 and DocuReader 2 Pro ................................................................................................................ 168

Urinary Tract Infection Tests ...................................................................................................................................................168ACON Laboratories’ Mission UTI Urinary Tract Infection Test Strips ........................................................................................... 168Jant Pharmacal’s Accutest Uriscreen Rapid UTI Screen Test ....................................................................................................... 168Orion Diagnostica’s Uricult Dipslide Tests ....................................................................................................................................... 168

Microalbumin Testing .............................................................................................................................................................169Axis-Shield’s Afinion ACR Test ............................................................................................................................................................ 169Biomerica’s Fortel Microalbumin Screening-OTC Test .................................................................................................................. 169

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Orion Diagnostica’s QuikRead U-ALB ............................................................................................................................................... 169Quest Diagnostics’ HemoCue Albumin 201 System .......................................................................................................................170Sekisui Diagnostics’ OSOM ImmunoDip Urinary Albumin Test ....................................................................................................170Siemens’ Clinitek Microalbumin Strips .............................................................................................................................................170

POC FERTILITY AND PREGNANCY TESTING ............................................................................................................................ 171Fig.18: Global POC Pregnancy & Fertility Market, 2007-2016E (US$ million) ............................................................................................................................................ 171

Competitive Landscape - Pregnancy Testing Kits ................................................................................................................171In Development - Bio-AMD’s DSR ...................................................................................................................................................... 173

Competitive Landscape - Ovulation Testing Kits .................................................................................................................173Competitive Landscape - Menopause Testing Kits ..............................................................................................................174SPD Swiss Precision Diagnostics’ Consumer Products ........................................................................................................174Mitsubishi Chemical’s Pathfast Immunoassay Analyzer .....................................................................................................175ContraVac’s SpermCheck Male Fertility Testing Products ...................................................................................................175

SpermCheck Fertility ...........................................................................................................................................................................175SpermCheck Vasectomy ......................................................................................................................................................................176

Labour and Delivery Testing ..................................................................................................................................................176Alere’s Triage PLGF Assay .....................................................................................................................................................................176Amnisure International’s AmniSure ROM Test................................................................................................................................ 177Medix Biochemica’s Actim PROM and Actim Partus...................................................................................................................... 177

POC DRUGS-OF-ABUSE TESTING .............................................................................................................................................. 178Market Dynamics .....................................................................................................................................................................178

Currently-Available POC Drugs-of-Abuse Testing Products ....................................................................................................................................................................... 179DoA Product Highlights ...................................................................................................................................................................... 180

Alere’s Tests ......................................................................................................................................................................................................................................180Alfa Scientific Designs’ Drug Screen Tests ....................................................................................................................................................................................... 181American Bio Medica’s Drug Abuse Tests ....................................................................................................................................................................................... 181Branan Medical’s Oratect III and OratectPlus Devices .................................................................................................................................................................... 182Phamatech Drugs of Abuse Tests .................................................................................................................................................................................................... 182Randox Laboratories’ Evidence Multistat ....................................................................................................................................................................................... 183

Products in Development ................................................................................................................................................................... 183Concateno’s New Portable Drug Testing System ............................................................................................................................................................................ 183

Alcohol Testing ..................................................................................................................................................................................... 184ACON Laboratories' Alcohol Testing Products .................................................................................................................................................................................184Alere’s Products................................................................................................................................................................................................................................184Akers Biosciences’ BreathScan ........................................................................................................................................................................................................184BreathScan PRO ...............................................................................................................................................................................................................................184Chematics’ Alco-Screen ................................................................................................................................................................................................................... 185OraSure’s Q.E.D. Saliva Alcohol Test ................................................................................................................................................................................................. 185In Development - TruTouch Technologies’ TruTouch 2000 System ................................................................................................................................................ 185

OTHER POC PRODUCTS.............................................................................................................................................................. 186Liver Function Testing .............................................................................................................................................................186

Exalenz Bioscience’s BreathID System ............................................................................................................................................. 186Infopia’s Pioneer POCT Liver Test Sensor ......................................................................................................................................... 186

Thyroid Tests ............................................................................................................................................................................186Screening Devices Canada’s ThyroChek .......................................................................................................................................... 186

Akers Biosciences’ Lithium “Check” System .........................................................................................................................187Alere’s Triage NGAL Test .........................................................................................................................................................187Ani Biotech’s Biocard Coeliac Tests ........................................................................................................................................188bioMérieux’ VIDAS B·R·A·H·M·S PCT. Test .............................................................................................................................188Magellan Biosciences’ LeadCare II System ............................................................................................................................188Biomerica’s Fortel Pet Allergy Tests .......................................................................................................................................189

EMERGING TECHNOLOGIES....................................................................................................................................................... 190Alere’s True Rapid Molecular Platform ..................................................................................................................................191Atonomics’ Atolyzer ................................................................................................................................................................191Ativa's POC System ..................................................................................................................................................................191

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Bio-AMD’s MPR ........................................................................................................................................................................192Cepheid’s GeneXpert ..............................................................................................................................................................192

Xpert MTB/RIF ....................................................................................................................................................................................... 193Xpert HIV Viral Load Test .................................................................................................................................................................... 193

Claros Diagnostics’ Claros System .........................................................................................................................................194pes diagnosesysteme’ respons IQ ..........................................................................................................................................194Enigma Diagnostics’ Enigma ML (Mini Laboratory) .............................................................................................................195IQuum’s Liat System ................................................................................................................................................................195

Liat Assays .............................................................................................................................................................................................. 196Molecular Vision .....................................................................................................................................................................196MycroLab ..................................................................................................................................................................................197Ortho-Clinical Diagnostics’ (Johnson & Johnson) Forecast System ....................................................................................197Philips’ Magnotech ..................................................................................................................................................................198Randox Laboratories’ Lab-on-a-Chip ...................................................................................................................................199T2 Biosystems’ T2Dx System ..................................................................................................................................................199TwistDx’ Recombinase Polymerase Amplification Technology ......................................................................................... 200Tyrian Diagnostics’ DiagnostIQ .............................................................................................................................................201

POC MANUFACTURERS ................................................................................................................................ 202POC COMPANIES DIRECTORY....................................................................................................................................................202SELECTED COMPANY PROFILES ................................................................................................................................................ 210

Abaxis .......................................................................................................................................................................................210Piccolo xpress ........................................................................................................................................................................................ 210Litigation with Cepheid ........................................................................................................................................................................211Financial Performance .........................................................................................................................................................................211Abaxis Operating Results, 2005-2010 (US$ million) .................................................................................................................................................................................. 211

Latest Results ................................................................................................................................................................................................................................... 212Abbott ......................................................................................................................................................................................213

i-STAT Point-of-Care Products .............................................................................................................................................................213Cartridges ......................................................................................................................................................................................................................................... 213

Diabetes Care .........................................................................................................................................................................................214FreeStyle Navigator Continuous Glucose Monitoring System........................................................................................................................................................ 214FreeStyle Blood Glucose Monitors and Test Strips .......................................................................................................................................................................... 214Precision Xtra/Optium Xceed System .............................................................................................................................................................................................. 214CoPilot Health Management System .............................................................................................................................................................................................. 215Professional Products ...................................................................................................................................................................................................................... 215Test Strip Product Recall .................................................................................................................................................................................................................. 215

Current Alliances ...................................................................................................................................................................................215CoaguSense ..................................................................................................................................................................................................................................... 215Calypte Biomedical .......................................................................................................................................................................................................................... 215

Litigation ................................................................................................................................................................................................216Church & Dwight .............................................................................................................................................................................................................................. 216Bayer ................................................................................................................................................................................................................................................. 216DexCom ........................................................................................................................................................................................................................................... 216Nova Biomedical .............................................................................................................................................................................................................................. 216

Financial Performance .........................................................................................................................................................................217Abbott Diagnostics Sales, 2005-2010 (US$ million)................................................................................................................................................................................... 217Fig.19: Percentage of Abbott Diagnostics Revenue by Region, 2010.......................................................................................................................................................... 217Abbott Diabetes Care Sales by Region, 2005-2010 (US$ million) .............................................................................................................................................................. 218Fig.20: Percentage of Abbott Diabetes Care Revenue by Region, 2010 ...................................................................................................................................................... 218

Accumetrics .............................................................................................................................................................................219Recent Key Events ....................................................................................................................................................................................................................................... 219Fig.21: Accumetrics Revenue, 2005-2010 (US$ thousand) ......................................................................................................................................................................... 219VerifyNow System ................................................................................................................................................................................ 220Distribution Agreements .................................................................................................................................................................... 220

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ACON Laboratories ................................................................................................................................................................. 222Recent Key Events .......................................................................................................................................................................................................................................222On Call Blood Glucose Monitoring Systems .................................................................................................................................... 222Mission Clinical Chemistry Products ................................................................................................................................................ 223

Mission Hb Hemoglobin Testing System ........................................................................................................................................................................................223Mission FOB Reagent Strips ............................................................................................................................................................................................................223Urine Analysers and Test Strips .......................................................................................................................................................................................................223

Alcohol Testing ..................................................................................................................................................................................... 223Akers Bioscienes .................................................................................................................................................................... 224

Recent Key Events ....................................................................................................................................................................................................................................... 224Current Products .................................................................................................................................................................................. 225

PIFA Heparin/PF4 Rapid Assay ........................................................................................................................................................................................................225BreathScan .......................................................................................................................................................................................................................................226BreathScan PRO ...............................................................................................................................................................................................................................226Breath Ketone “Check” ...................................................................................................................................................................................................................226Battlefield Blood Transfusion Card..................................................................................................................................................................................................227Lithium “Check” System ..................................................................................................................................................................................................................227Tri-Cholesterol Check .......................................................................................................................................................................................................................227Non Core Products ...........................................................................................................................................................................................................................227

Research and Development ............................................................................................................................................................... 227BreathPulmo Health “Check” ..........................................................................................................................................................................................................227

Current Alliances and Distribution Agreements ............................................................................................................................ 228Al Tadawi Medical Equip ..................................................................................................................................................................................................................228HealthTrust Purchasing Group .........................................................................................................................................................................................................228Fisher HealthCare .............................................................................................................................................................................................................................228BreathScan International ................................................................................................................................................................................................................228US Government Service Administration Schedule Contract ..........................................................................................................................................................228AFRICA Continental Holdings ..........................................................................................................................................................................................................228PULSE Health ....................................................................................................................................................................................................................................228

Financial Performance ........................................................................................................................................................................ 229Akers Biosciences Operating Results, 2005-2009 (US$ thousands) ...........................................................................................................................................................229

Latest Results ...................................................................................................................................................................................................................................229Alere ......................................................................................................................................................................................... 230

Recent Key Events ....................................................................................................................................................................................................................................... 231POC Professional Diagnostic Products ............................................................................................................................................. 231

Cardiology ........................................................................................................................................................................................................................................ 231Women’s Health ...............................................................................................................................................................................................................................232Infectious Diseases ...........................................................................................................................................................................................................................233Oncology ..........................................................................................................................................................................................................................................234Drugs of Abuse .................................................................................................................................................................................................................................234

Consumer Products ............................................................................................................................................................................. 234First Check Consumer Diagnostics Products ...................................................................................................................................................................................234Standard Diagnostics’ Blood Glucose Meters .................................................................................................................................................................................235

Research and Development ............................................................................................................................................................... 235POC Mergers & Acquisitions ............................................................................................................................................................... 235

Standard Diagnostics .......................................................................................................................................................................................................................235Assets from Unotech Diagnostics ....................................................................................................................................................................................................235Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp ....................................................................................................................................236Genecare, Zycare, Medim and Biosyn .............................................................................................................................................................................................236Concateno ........................................................................................................................................................................................................................................236ACON Laboratories’ Rapid Diagnostics Assets ................................................................................................................................................................................236Vision Biotech and Global Diagnostics CC .......................................................................................................................................................................................236Matria Healthcare ............................................................................................................................................................................................................................237BBI Holdings ....................................................................................................................................................................................................................................237Panbio...............................................................................................................................................................................................................................................237

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Earlier Acquisitions ...........................................................................................................................................................................................................................237Joint Ventures ....................................................................................................................................................................................... 239

SPD Swiss Precision Diagnostics ......................................................................................................................................................................................................239Current Alliances .................................................................................................................................................................................. 239

Spartan Bioscience ...........................................................................................................................................................................................................................239Epocal ...............................................................................................................................................................................................................................................239OraSure Technologies ......................................................................................................................................................................................................................239Mediwatch .......................................................................................................................................................................................................................................240Chembio ...........................................................................................................................................................................................................................................240Trinity Biotech ..................................................................................................................................................................................................................................240ContraVac .........................................................................................................................................................................................................................................240

Litigation ................................................................................................................................................................................................ 240OraSure Technologies ......................................................................................................................................................................................................................240

Financial Performance ........................................................................................................................................................................ 241Alere - Operating Results, 2006-2010 (US$ million) .................................................................................................................................................................................. 242Fig.22: Percentage of Alere’s Revenue by Segment, 2010 .......................................................................................................................................................................... 242Fig.23: Percentage of Alere’s Revenue by Product Type, 2010 .................................................................................................................................................................... 242Fig.24: Percentage of Alere’s Revenue by Region, 2010 ............................................................................................................................................................................. 243Alere Professional Diagnostics Operating Results, 2006-2010 (US$ million) ............................................................................................................................................ 243Alere Consumer Diagnostics Operating Results, 2006-2010 (US$ million) ................................................................................................................................................ 243

American Bio Medica.............................................................................................................................................................. 244Recent Key Events .......................................................................................................................................................................................................................................244Drug Abuse Tests .................................................................................................................................................................................. 244

Urine Tests ........................................................................................................................................................................................................................................244Saliva Tests ....................................................................................................................................................................................................................................... 245Rapid Reader .................................................................................................................................................................................................................................... 245Adulteration, Alcohol and Nicotine Products..................................................................................................................................................................................246

Current Alliances .................................................................................................................................................................................. 246Hema Diagnostic Systems ...............................................................................................................................................................................................................246

Financial Performance ........................................................................................................................................................................ 246American Bio Medica Operating Results, 2006-2010 (US$ million) ..........................................................................................................................................................246

Arkray .......................................................................................................................................................................................247Recent Key Events ....................................................................................................................................................................................................................................... 247SpotChem EZ Dry Chemistry Analyser ............................................................................................................................................ 247SpotChem EL Electrolyte Analyser .................................................................................................................................................... 247PocketChem BA Blood Ammonia Meters ........................................................................................................................................ 248Urinalysis ................................................................................................................................................................................................ 248

DiaScreen 50 Urine Chemistry Analyzer..........................................................................................................................................................................................248PocketChem UA ................................................................................................................................................................................................................................248AUTION ELEVEN ................................................................................................................................................................................................................................248

Blood Glucose Self-Testing ................................................................................................................................................................. 248Glucocard Meters ............................................................................................................................................................................................................................248Assure Blood Glucose Testing Products .......................................................................................................................................................................................... 249

Current Alliances .................................................................................................................................................................................. 250ELITech Group ...................................................................................................................................................................................................................................250Nipro .................................................................................................................................................................................................................................................250MyCareTeam ....................................................................................................................................................................................................................................250A Menarini Diagnostics ....................................................................................................................................................................................................................250

Axis-Shield ...............................................................................................................................................................................251Recent Key Events ....................................................................................................................................................................................................................................... 251Afinion POC System ............................................................................................................................................................................. 251NycoCard ............................................................................................................................................................................................... 252Coagulation Products .......................................................................................................................................................................... 253Financial Performance ........................................................................................................................................................................ 253Fig.25: Axis-Shield Revenue by Business Unit, 2010 ...................................................................................................................................................................................254

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Fig.26: Axis-Shield Revenue by Region, 2010 ............................................................................................................................................................................................. 255Axis-Shield - POC Segment Operating Results, 2006-2010 (£ million) ...................................................................................................................................................... 255Axis-Shield - POC Sales by Product Line, 2006-2010 (£ million)................................................................................................................................................................. 255Fig.27: Axis-Shield POC Sales by Product, 2010 ..........................................................................................................................................................................................256Fig.28: Axis-Shield Afinion Sales by Region, 2010 ......................................................................................................................................................................................256

Bayer .........................................................................................................................................................................................257Blood Glucose Monitoring Systems .................................................................................................................................................. 257

DIDGET Meter ...................................................................................................................................................................................................................................257Contour USB .....................................................................................................................................................................................................................................257Contour, Contour TS, Contour Link and Breeze 2 ............................................................................................................................................................................258Elite and Elite XL ...............................................................................................................................................................................................................................258

A1CNow Products ................................................................................................................................................................................. 258Current Alliances .................................................................................................................................................................................. 259

Medtronic .........................................................................................................................................................................................................................................259Litigation ................................................................................................................................................................................................ 259

Abbott ..............................................................................................................................................................................................................................................259Roche Diagnostics ............................................................................................................................................................................................................................259

Financial Performance ........................................................................................................................................................................ 259Bayer Diabetes Care Revenue, 2005-2010 (EUR million) ........................................................................................................................................................................... 259

Beckman Coulter .................................................................................................................................................................... 260Rapid Tests ............................................................................................................................................................................................. 260

Hemoccult Tests ..............................................................................................................................................................................................................................260Gastroccult .......................................................................................................................................................................................................................................260

Haematology Analysers ..................................................................................................................................................................... 261Biomerica ................................................................................................................................................................................ 262

Home Diagnostic Products ................................................................................................................................................................. 262Professional Use Products .................................................................................................................................................................. 263IVAX Diagnostics Distribution Alliance ............................................................................................................................................ 263Financial Performance ........................................................................................................................................................................ 263Biomerica - Operating Results, 2006-2010 (US$ thousand) ...................................................................................................................................................................... 263Biomerica - Revenue by Region, 2008-2010 (US$ thousand) ....................................................................................................................................................................264Fig.29: Percentage of Biomerica’s Revenue by Region, 2010 .....................................................................................................................................................................264

Latest Results ...................................................................................................................................................................................................................................264bioMérieux .............................................................................................................................................................................. 265

Emergency Care ................................................................................................................................................................................... 265VIDAS NT-proBNP ............................................................................................................................................................................................................................265VIDAS Troponin I Ultra......................................................................................................................................................................................................................265VIDAS D-Dimer Exclusion .................................................................................................................................................................................................................265VIDAS B·R·A·H·M·S PCT. Test .............................................................................................................................................................................................................266

Rapid Infectious Disease Tests ........................................................................................................................................................... 266VIKIA HIV1/2 HIV Test .......................................................................................................................................................................................................................266VIKIA HBs Ag Hepatitis B Test ..........................................................................................................................................................................................................266

Current Alliances .................................................................................................................................................................................. 266Philips ...............................................................................................................................................................................................................................................266Quidel ...............................................................................................................................................................................................................................................267Sysmex .............................................................................................................................................................................................................................................267Abaxis ...............................................................................................................................................................................................................................................267ReLIA Diagnostic Systems ................................................................................................................................................................................................................267Roche Diagnostics ............................................................................................................................................................................................................................ 267Brahms ............................................................................................................................................................................................................................................. 267

Financial Performance ........................................................................................................................................................................ 267bioMérieux - Operating Results, 2006-2010 (EUR million) ........................................................................................................................................................................268Fig.30: Percentage of bioMérieux’s Revenue by Product Type, 2010 ..........................................................................................................................................................268Fig.31: Percentage of bioMérieux’s Revenue by Region, 2010 ....................................................................................................................................................................269

Bio-Rad Laboratories .............................................................................................................................................................270

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Point-of-Care HbA1c Testing .............................................................................................................................................................. 270TOX/See Drugs-of-Abuse Testing ...................................................................................................................................................... 270Multispot HIV-1/HIV-2 Rapid Test ...................................................................................................................................................... 270Current Alliances .................................................................................................................................................................................. 271

Chembio .......................................................................................................................................................................................................................................... 271Calypte Biomedical .......................................................................................................................................................................................................................... 271

Calypte Biomedical .................................................................................................................................................................272Aware Rapid Test Product Line .......................................................................................................................................................... 272

Aware HIV-1/2 OMT (Oral fluid) ......................................................................................................................................................................................................273Aware HIV-1/2 BSP ..........................................................................................................................................................................................................................273Aware HIV-1/2 U ...............................................................................................................................................................................................................................273

Products in Development - Aware II (The Ani Platform) ............................................................................................................... 273Current Alliances .................................................................................................................................................................................. 273

Manufacturing Contracts ................................................................................................................................................................................................................ 274Financial Performance .........................................................................................................................................................................274Calypte Biomedical Operating Results, 2006-2010 (US$ thousands) ........................................................................................................................................................ 274Fig.32: Percentage of Calypte’s Revenue by Product, 9 Months 2010 ........................................................................................................................................................ 275

Chembio Diagnostics ..............................................................................................................................................................276Recent Key Events ....................................................................................................................................................................................................................................... 276Rapid HIV Tests ..................................................................................................................................................................................... 277Dual Path Platform Technology Products ...................................................................................................................................... 277

DPP HIV 1/2 Screening Assay ...........................................................................................................................................................................................................277DPP HIV 1/2 Confirmatory Test ........................................................................................................................................................................................................ 278

Other Tests ............................................................................................................................................................................................. 278DPP Technology Products in Development .................................................................................................................................... 278

DPP Tuberculosis ............................................................................................................................................................................................................................. 278DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests ............................................................................................................................................. 279DPP Influenza ..................................................................................................................................................................................................................................279DPP Leptospirosis ............................................................................................................................................................................................................................279DPP Syphilis Screen & Confirm ........................................................................................................................................................................................................280

Current Alliances .................................................................................................................................................................................. 280Oswaldo Cruz Foundation of Brazil .................................................................................................................................................................................................280Battelle Memorial Institute .............................................................................................................................................................................................................280Alere .................................................................................................................................................................................................................................................281US CDC ..............................................................................................................................................................................................................................................281Infectious Disease Research Institute..............................................................................................................................................................................................281Bio-Rad Laboratories .......................................................................................................................................................................................................................281

Financial Performance ........................................................................................................................................................................ 282Chembio - Operating Results, 2006-2010 (US$ thousands) ......................................................................................................................................................................282Chembio - Revenue by Type, 2008-2010 (US$ thousand) ..........................................................................................................................................................................283Chembio - Product Sales by Region, 2006-2010 (US$ thousand) ..............................................................................................................................................................283Fig.33: Percentage of Chembio’s Revenue by Type, 2010 ...........................................................................................................................................................................283Fig.34: Percentage of Chembio’s Product Sales by Region, 2010 ...............................................................................................................................................................284

DexCom ................................................................................................................................................................................... 285SEVEN PLUS CGM System .................................................................................................................................................................... 285

FDA Warning Letter .........................................................................................................................................................................................................................285GlucoClear ............................................................................................................................................................................................. 285Research and Development ............................................................................................................................................................... 286Current Alliances .................................................................................................................................................................................. 286

Edwards Lifesciences .......................................................................................................................................................................................................................286Insulet ...............................................................................................................................................................................................................................................286Animas..............................................................................................................................................................................................................................................286

Litigation with Abbott ........................................................................................................................................................................ 286Financial Performance ........................................................................................................................................................................ 287DexCom - Operating Results, 2006-2010 (US$ thousands) .......................................................................................................................................................................288

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Horiba ABX .............................................................................................................................................................................. 289Haematology Analysers ...................................................................................................................................................................... 289

ABX Micros ES60...............................................................................................................................................................................................................................289ABX Micros 60 ...................................................................................................................................................................................................................................289ABX Micros CRP 200 .........................................................................................................................................................................................................................289ABX E-Sat ..........................................................................................................................................................................................................................................289ABX Pentra 60C+ .............................................................................................................................................................................................................................290

ABX Pentra 400 Clinical Chemistry Analyser ................................................................................................................................... 290Financial Performance ........................................................................................................................................................................ 290Fig.35: Percentage of Horiba’s Revenue by Division, 2010 .........................................................................................................................................................................290Horiba Medical Operating Results, 2006-2010 (¥ million) ........................................................................................................................................................................ 291Fig.36: Percentage of Horiba Medical’s Revenue by Region, 2010 ............................................................................................................................................................. 291

Instrumentation Laboratory ..................................................................................................................................................292Recent Key Events ....................................................................................................................................................................................................................................... 292POC Critical Care Diagnostics ............................................................................................................................................................. 293

tBili Assay .........................................................................................................................................................................................................................................293GEMweb Plus Custom Connectivity ................................................................................................................................................................................................293

Purchasing Contracts ........................................................................................................................................................................... 294LifeScan ................................................................................................................................................................................... 295

Recent Key Events .......................................................................................................................................................................................................................................295Blood Glucose Monitoring Products ................................................................................................................................................ 295

Consumer Products ..........................................................................................................................................................................................................................296Hospital Products .............................................................................................................................................................................................................................297Test Strips .........................................................................................................................................................................................................................................298

OneTouch Diabetes Management Software .................................................................................................................................. 298DataLink Data Management System ................................................................................................................................................ 299Current Alliances .................................................................................................................................................................................. 299

Medtronic .........................................................................................................................................................................................................................................299Financial Performance ........................................................................................................................................................................ 299J&J Diabetes Care Revenue 2005-2010 (US$ million) ................................................................................................................................................................................299Fig.37: LifeScan Sales by Region, 2010 .......................................................................................................................................................................................................300Fig.38: LifeScan Sales, 2004-2010 (US$ million) ........................................................................................................................................................................................300

MedMira ..................................................................................................................................................................................301Recent Key Events .......................................................................................................................................................................................................................................301Rapid Tests ............................................................................................................................................................................................. 302

Multiplo HIV/HCV .............................................................................................................................................................................................................................302Multiplo HBV/HIV/HCV .....................................................................................................................................................................................................................302HIV Tests ...........................................................................................................................................................................................................................................303Reveal/MiraWell hp Test H. pylori Test ............................................................................................................................................................................................304

R&D Activities ........................................................................................................................................................................................ 304New Combination Tests ...................................................................................................................................................................................................................304

Current Alliances .................................................................................................................................................................................. 304Advance Aid......................................................................................................................................................................................................................................304Triplex International Biosciences .....................................................................................................................................................................................................304VWR International ...........................................................................................................................................................................................................................305Tri-Star Industries .............................................................................................................................................................................................................................305Vitest ................................................................................................................................................................................................................................................305Shenzhen Kang Sheng Bao Bio-Technology ...................................................................................................................................................................................305Pan American Health Organization .................................................................................................................................................................................................305HealthCare Asia MediTech ...............................................................................................................................................................................................................306INyDIA Diagnóstico ..........................................................................................................................................................................................................................306Voden Medical Instruments ...........................................................................................................................................................................................................306IKXUR ................................................................................................................................................................................................................................................306

Financial Performance ........................................................................................................................................................................ 306MedMira Operating Results, 2006-2010 (C$ thousands) ..........................................................................................................................................................................306

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MedMira - Revenue by Region, 2007-2010 (C$ thousands) .......................................................................................................................................................................307Fig.39: MedMira - Revenue by Region, 2010 ..............................................................................................................................................................................................307

Latest Results ...................................................................................................................................................................................................................................307Medtronic ................................................................................................................................................................................ 308

CGM Systems ......................................................................................................................................................................................... 308Recent Key Events .......................................................................................................................................................................................................................................309

Paradigm Veo ..................................................................................................................................................................................................................................309Paradigm REAL-Time Revel .............................................................................................................................................................................................................309Guardian REAL-Time System ........................................................................................................................................................................................................... 310iPro Professional Use Products ........................................................................................................................................................................................................ 310CareLink Pro 3.0 Therapy Management Software ......................................................................................................................................................................... 310Blood Glucose Meters ..................................................................................................................................................................................................................... 311Clinical Trials ..................................................................................................................................................................................................................................... 311Research and Development ............................................................................................................................................................................................................ 312Alliances - LifeScan and Bayer ........................................................................................................................................................................................................ 313

Cardiac Surgery POC Products ............................................................................................................................................................313ACT Plus Automated Coagulation Timer System ............................................................................................................................................................................ 313HMS PLUS Haemostasis Management System ............................................................................................................................................................................... 313

Financial Performance .........................................................................................................................................................................313Fig.40: Medtronic Diabetes Revenue, 2005-2010 (US$ million)................................................................................................................................................................. 314Fig.41: Medtronic Diabetes Revenue by Region, 2010 ................................................................................................................................................................................ 314Fig.42: Medtronic Diabetes Revenue by Product Type, 2010 ...................................................................................................................................................................... 315

Latest Results .................................................................................................................................................................................................................................. 315Meridian Bioscience ................................................................................................................................................................316

TRU FLU and TRU RSV ...........................................................................................................................................................................316C.difficile Tests .......................................................................................................................................................................................316ImmunoCard STAT! HpSA H. pylori Test ............................................................................................................................................316ImmunoCard STAT! Rotavirus .............................................................................................................................................................316ImmunoCard STAT! Strep A .................................................................................................................................................................316ImmunoCard STAT! MONO ..................................................................................................................................................................317ImmunoCard STAT! hCG Combo Test .................................................................................................................................................317Financial Performance .........................................................................................................................................................................317Meridian Bioscience Operating Results, 2006-2010 (US$ million) ............................................................................................................................................................. 317Meridian Bioscience - Third-Party Sales by Segment, 2006-2010 (US$ million) ....................................................................................................................................... 318Meridian Bioscience - Operating Income by Segment, 2006-2010 (US$ million) ...................................................................................................................................... 318Fig.43: Meridian Bioscience - Revenue by Segment, 2010 ......................................................................................................................................................................... 318Meridian Bioscience - European Diagnostics Sales by Country, 2005-2010 (US$ million) ......................................................................................................................... 318

Latest Results and Outlook .............................................................................................................................................................................................................. 319Nexus Dx ...................................................................................................................................................................................320

Recent Key Events .......................................................................................................................................................................................................................................320Products ................................................................................................................................................................................................. 321

ProTime Coagulation Systems ......................................................................................................................................................................................................... 321Hemochron Whole Blood Coagulation System .............................................................................................................................................................................. 321IRMA TRUpoint Blood Analysis System ...........................................................................................................................................................................................322AVOXimeter Whole Blood CO Oximeter and Oximeter ...................................................................................................................................................................322Hgb Pro Professional Hemoglobin Testing System ........................................................................................................................................................................322POC Cardiovascular Tests .................................................................................................................................................................................................................322

Products in Development ................................................................................................................................................................... 323Current Alliances .................................................................................................................................................................................. 323

Medical Automation Systems .........................................................................................................................................................................................................323Financial Performance - ITC ................................................................................................................................................................ 323International Technidyne Operating Results, 2004-2009 (US$ million) .................................................................................................................................................... 324Fig.44: International Technidyne Revenue, 2000-2010 (US$ million) ....................................................................................................................................................... 324

Nipro Diagnostics ...................................................................................................................................................................325TRUEtest Test Strips ............................................................................................................................................................................. 325

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TRUE2go and TRUEresult .................................................................................................................................................................... 325TRUEread ............................................................................................................................................................................................... 326TRUEmanager Diabetes Management Software .......................................................................................................................... 326Current Alliances .................................................................................................................................................................................. 326

Cellnovo ............................................................................................................................................................................................................................................ 326Financial Performance ........................................................................................................................................................................ 327Home Diagnostics - Operating Results, 2004-2008 (US$ million) ............................................................................................................................................................. 327Home Diagnostics - Revenue by Source, 2006-2008 (US$ million) ........................................................................................................................................................... 328Fig.45: Percentage of Home Diagnostics’ Revenue by Source, 2008 .......................................................................................................................................................... 328

Nova Biomedical ......................................................................................................................................................................329Recent Key Events ....................................................................................................................................................................................................................................... 329StatStrip Hospital Blood Glucose Analysers .................................................................................................................................... 329Statsensor Creatinine Meter .............................................................................................................................................................. 330StatStrip Lactate ................................................................................................................................................................................... 330Whole Blood Stat Testing .................................................................................................................................................................... 330

Stat Profile Critical Care Xpress ....................................................................................................................................................................................................... 330Stat Profile pHOx ............................................................................................................................................................................................................................. 330

Nova Electrolyte/Chemistry Analysers ............................................................................................................................................ 331Self-Testing Blood Glucose Analysers ............................................................................................................................................... 331

Nova Max Plus .................................................................................................................................................................................................................................. 331Nova Max Link .................................................................................................................................................................................................................................. 331

Current Alliances and Contracts ........................................................................................................................................................ 331Premier ............................................................................................................................................................................................................................................. 331HealthTrust Purchasing Group ......................................................................................................................................................................................................... 331

Litigation ............................................................................................................................................................................................... 332Roche Diagnostics ............................................................................................................................................................................................................................ 332Medtronic ......................................................................................................................................................................................................................................... 332Abbott .............................................................................................................................................................................................................................................. 332

OraSure Technologies .............................................................................................................................................................333Recent Key Events ....................................................................................................................................................................................................................................... 333OraQuick Rapid Test Platform ............................................................................................................................................................ 333

OraQuick HCV Rapid Antibody Test ................................................................................................................................................................................................334OraQuick ADVANCE HIV-1/2 ............................................................................................................................................................................................................334

OraSure QuickFlu Rapid Flu A+B Test ............................................................................................................................................... 334Q.E.D. Saliva Alcohol Test .................................................................................................................................................................... 335Products in Development ................................................................................................................................................................... 335Current Alliances and Licensing Agreements ................................................................................................................................. 335

Princeton BioMeditech .................................................................................................................................................................................................................... 335Alere ................................................................................................................................................................................................................................................. 335Premier ............................................................................................................................................................................................................................................. 335Merck ................................................................................................................................................................................................................................................336Ortho-Clinical Diagnostics ...............................................................................................................................................................................................................336

Financial Performance ........................................................................................................................................................................ 336OraSure - Operating Results, 2006-2010 (US$ million).............................................................................................................................................................................. 337OraSure Infectious Disease Testing Sales, 2009-2010 (US$ thousands) ..................................................................................................................................................... 337Fig.46: OraSure - Revenue by Business Area, 2010 .................................................................................................................................................................................... 337Fig.47: OraQuick HIV Revenue by Region, 2010.......................................................................................................................................................................................... 338

Orion Diagnostica ....................................................................................................................................................................339QuikRead System ................................................................................................................................................................................. 339QuikRead go ......................................................................................................................................................................................... 339Uricult Dipslide Tests ........................................................................................................................................................................... 339Rotaviral and Adenoviral Enteritis Tests ..........................................................................................................................................340Orion Q-flow FOB .................................................................................................................................................................................340Financial Performance ........................................................................................................................................................................ 341Orion Diagnostica - Operating Results, 2006-2010 (EUR million) ............................................................................................................................................................. 341

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OrSense ................................................................................................................................................................................... 342NBM-200MP Multi-Parameter Sensor .............................................................................................................................................. 342

NBM-200MP Oximetry ....................................................................................................................................................................................................................342NBM 200 Haemoglobin ...................................................................................................................................................................................................................343In Development - NBM-200G Blood Glucose Meter .......................................................................................................................................................................343

Phamatech .............................................................................................................................................................................. 344Drugs of Abuse Tests ...........................................................................................................................................................................344

At Home Drug Test ...........................................................................................................................................................................................................................344QuickScreen......................................................................................................................................................................................................................................344QuickScreen Plus ..............................................................................................................................................................................................................................344QuickScreen Cup ..............................................................................................................................................................................................................................344QuickScreen Dipsticks and Cassettes ..............................................................................................................................................................................................344

Pregnancy and Fertility Testing ......................................................................................................................................................... 345Quest Diagnostics ................................................................................................................................................................... 346

HemoCue Products ..............................................................................................................................................................................346Haemoglobin Systems .....................................................................................................................................................................................................................346Blood Glucose Testing ......................................................................................................................................................................................................................347HemoCue Albumin 201 System .......................................................................................................................................................................................................347HemoCue White Blood Cell Analyzer ..............................................................................................................................................................................................348

Enterix Products ...................................................................................................................................................................................348InSure Quik F I T Fecal Immunochemical Test .................................................................................................................................................................................348

Focus Diagnostics’ POC Products ...................................................................................................................................................... 349HerpeSelect Express HSV-2 ..............................................................................................................................................................................................................349Focus Dengue Rapid Tests ...............................................................................................................................................................................................................349

Current Alliances .................................................................................................................................................................................. 350Roche ................................................................................................................................................................................................................................................350

Financial Performance ........................................................................................................................................................................ 350Quest Diagnostics - Operating Results, 2006-2010 (US$ million) .............................................................................................................................................................. 350Quest Diagnostics - Sales and Earnings by Category, 2006-2010 (US$ million) ....................................................................................................................................... 351Fig.48: Quest Diagnostics - Revenue by Division, 2010 .............................................................................................................................................................................. 351Fig.49: Quest Diagnostics - Revenue by Product Type, 2010 ...................................................................................................................................................................... 351

Quidel ......................................................................................................................................................................................352Recent Key Events ....................................................................................................................................................................................................................................... 352Infectious Disease Tests ...................................................................................................................................................................... 352

QuickVue Influenza Tests ................................................................................................................................................................................................................. 352QuickVue Group A Strep Tests .......................................................................................................................................................................................................... 353QuickVue RSV Tests .......................................................................................................................................................................................................................... 353QuickVue+ Infectious Mononucleosis ............................................................................................................................................................................................ 353

Reproductive and Women’s Health .................................................................................................................................................. 353QuickVue iFOB ...................................................................................................................................................................................... 353QuickVue H. Pylori gII Test .................................................................................................................................................................. 354Current Alliances .................................................................................................................................................................................. 354

bioMérieux .......................................................................................................................................................................................................................................354Financial Performance ........................................................................................................................................................................ 354Quidel Operating Results, 2006-2010 (US$ million) .................................................................................................................................................................................. 355Quidel - Revenue by Product Type, 2008-2010 (US$ million) .................................................................................................................................................................... 355Fig.50: Quidel - Revenue by Product Type, 2010 ........................................................................................................................................................................................ 355Fig.51: Quidel Infectious Disease Revenue, 2005-2010 (US$ million) ........................................................................................................................................................ 356Quidel - Revenue by Region, 2005-2010 (US$ million) .............................................................................................................................................................................. 356Fig.52: Quidel - Revenue by Region, 2010 .................................................................................................................................................................................................. 356

Radiometer (Danaher) ............................................................................................................................................................357Recent Key Events ....................................................................................................................................................................................................................................... 357AQT90 FLEX Immunoassay Analyser ................................................................................................................................................ 357Blood Gas Analysers ............................................................................................................................................................................ 358

1st automatic ...................................................................................................................................................................................................................................358

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ABL80 FLEX .......................................................................................................................................................................................................................................358ABL90 FLEX ...................................................................................................................................................................................................................................... 359ABL800 FLEX .................................................................................................................................................................................................................................... 359ABL5 ................................................................................................................................................................................................................................................. 359

ABL80 FLEX CO-OX CO Oximeter ...................................................................................................................................................... 360RADIANCE IT system ............................................................................................................................................................................ 360Quality Control...................................................................................................................................................................................... 360Current Alliances .................................................................................................................................................................................. 360

Roche ................................................................................................................................................................................................................................................360Medical Automation Systems .........................................................................................................................................................................................................360

Financial Performance ........................................................................................................................................................................ 360Fig.53: Radiometer - Revenue by Region, 2010 ......................................................................................................................................................................................... 361

Response Biomedical ............................................................................................................................................................. 362Recent Key Events .......................................................................................................................................................................................................................................362RAMP System ........................................................................................................................................................................................ 363

Respiratory Syncytial Virus Test ......................................................................................................................................................................................................3633M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay ......................................................................................................................................................364RAMP NT-proBNP Test .....................................................................................................................................................................................................................364Other Cardiac Markers .....................................................................................................................................................................................................................364

Current Alliances .................................................................................................................................................................................. 365Cremascoli .......................................................................................................................................................................................................................................365Guangzhou Wondfo Biotech ...........................................................................................................................................................................................................365O&D Biotech ....................................................................................................................................................................................................................................365Roche ................................................................................................................................................................................................................................................3653M .....................................................................................................................................................................................................................................................365Shionogi ...........................................................................................................................................................................................................................................366

Financial Performance ........................................................................................................................................................................ 366Response Biomedical - Operating Results, 2006-2010 (C$ thousands) .....................................................................................................................................................367Response Biomedical - Product Sales by Category, 2009-2010 (C$ thousands) ........................................................................................................................................ 367Fig.54: Response Biomedical - Product Sales by Category, 2010 ............................................................................................................................................................... 367Response Biomedical - Revenue by Region, 2006-2010 (C$ thousands) ...................................................................................................................................................368Fig.55: Response Biomedical - Revenue by Region, 2010...........................................................................................................................................................................368

Roche Diagnostics .................................................................................................................................................................. 369Recent Key Events .......................................................................................................................................................................................................................................369Professional Diagnostic Products ..................................................................................................................................................... 370

CoaguChek Systems ......................................................................................................................................................................................................................... 370Cardiac Testing Products ................................................................................................................................................................................................................. 371cobas Blood Gas Analysers...............................................................................................................................................................................................................372Hospital Blood Glucose Monitoring................................................................................................................................................................................................. 372Urinalysis ..........................................................................................................................................................................................................................................373

Diabetes Care ........................................................................................................................................................................................ 373Blood Glucose Monitoring Products ...............................................................................................................................................................................................373Data Management Tools.................................................................................................................................................................................................................. 374

cobas POC IT Solution .......................................................................................................................................................................... 375Current Alliances and Contracts ........................................................................................................................................................ 375

Sanko Junyaku (Eisai) ....................................................................................................................................................................................................................... 375Voluntis ............................................................................................................................................................................................................................................. 375InterComponentWare...................................................................................................................................................................................................................... 375Premier Purchasing Partners ........................................................................................................................................................................................................... 375Radiometer ...................................................................................................................................................................................................................................... 376Response Biomedical ....................................................................................................................................................................................................................... 376bioMérieux ....................................................................................................................................................................................................................................... 376Alere ................................................................................................................................................................................................................................................. 376Dade Behring (Siemens) .................................................................................................................................................................................................................. 376

Litigation ................................................................................................................................................................................................ 376

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Nova Biomedical .............................................................................................................................................................................................................................. 376Bayer ................................................................................................................................................................................................................................................. 376

Financial Performance ........................................................................................................................................................................ 377Roche Diagnostics Operating Results, 2006-2010 (SFr million) ................................................................................................................................................................. 378Roche Diagnostics Sales by Product Line, 2007-2010 (SFr million) ............................................................................................................................................................ 378Roche Diagnostics Sales by Region, 2007-2010 (SFr million) ..................................................................................................................................................................... 378Fig.56: Roche Diagnostics - Revenue by Product Line, 2010 ...................................................................................................................................................................... 378Fig.57: Roche Diagnostics - Revenue by Region, 2010 ............................................................................................................................................................................... 379Fig.58: Roche Diabetes Care - Revenue by Region, 2010 ............................................................................................................................................................................ 379

Sekisui Diagnostics ................................................................................................................................................................ 380Point of Care Tests ................................................................................................................................................................................ 380

OSOM C. difficile Toxin A/B Test .......................................................................................................................................................................................................380OSOM Influenza A & B Test ..............................................................................................................................................................................................................380OSOM H. pylori .................................................................................................................................................................................................................................380OSOM Ultra Strep A ..........................................................................................................................................................................................................................381OSOM Strep A ...................................................................................................................................................................................................................................381OSOM Mono .....................................................................................................................................................................................................................................381OSOM Trichomonas Rapid Test ........................................................................................................................................................................................................381OSOM BVBLUE Test ...........................................................................................................................................................................................................................381OSOM ImmunoDip Urinary Albumin Test .......................................................................................................................................................................................381OSOM Pregnancy Tests ....................................................................................................................................................................................................................381

Siemens Healthcare ............................................................................................................................................................... 383Recent Key Events .......................................................................................................................................................................................................................................383

RAPIDLab Analysers .........................................................................................................................................................................................................................384RAPIDPoint Blood Gas Systems .......................................................................................................................................................................................................384RAPIDChem 744/754 Electrolyte and Lithium Testing ..................................................................................................................................................................384

Urinalysis ................................................................................................................................................................................................ 385Clinitek Advantus Analyzer ..............................................................................................................................................................................................................385Clinitek Status Analyser ...................................................................................................................................................................................................................385Clinitek Status+ ...............................................................................................................................................................................................................................385Clinitek Status Connect ....................................................................................................................................................................................................................385Multistix10 SG Reagent Strips .........................................................................................................................................................................................................385Clinitek Microalbumin Strips ...........................................................................................................................................................................................................386Clinitest hCG Pregnancy Test ...........................................................................................................................................................................................................386

RAPIDComm Data Management and Connectivity Solution ...................................................................................................... 386Diabetes Testing - DCA Vantage Analyser ....................................................................................................................................... 386Cardiology - Stratus CS Analyzer ....................................................................................................................................................... 387Current Alliances and Supply Contracts ........................................................................................................................................... 387

Novation ...........................................................................................................................................................................................................................................387Premier .............................................................................................................................................................................................................................................387Roche ................................................................................................................................................................................................................................................387Sysmex .............................................................................................................................................................................................................................................387

Financial Performance ........................................................................................................................................................................ 388Thermo Fisher Scientific ........................................................................................................................................................ 389

Sure-Vue Tests ....................................................................................................................................................................................... 389Remel’s Xpect Tests .............................................................................................................................................................................. 390

Trinity Biotech ..........................................................................................................................................................................391POC HIV Tests ........................................................................................................................................................................................ 391

Uni-Gold Recombigen HIV ............................................................................................................................................................................................................... 391Uni-Gold Legionella Urinary Antigen (LUA) .................................................................................................................................... 391Current Alliances .................................................................................................................................................................................. 392

Alere ................................................................................................................................................................................................................................................. 392Financial Performance ........................................................................................................................................................................ 392Trinity Biotech Operating Results, 2006-2010 (US$ million) ...................................................................................................................................................................... 392Trinity Biotech - Sales by Product Line, 2006-2010 (US$ million) .............................................................................................................................................................. 392

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APPENDICES .................................................................................................................................................. 393APPENDIX 1 - LIST OF ABBREVIATIONS ................................................................................................................................... 393APPENDIX 2 - REPORT METHODOLOGY ..................................................................................................................................394