POC Diagnostics- Future Players and Prospects

World Leaders in Health Industry Analysis

POC Diagnostics: Players, products & future market prospects

©Espicom Business Intelligence November 2009ii


November 2009

ISBN: 978 1 85822 359 9

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©Espicom Business Intelligence iiiNovember 2009

POC Diagnostics: Players, products & future market prospects Table of Contents

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

BACKGROUND............................................................................................................................................................................ 1The Role Of POC Testing ........................................................................................................................................................2

CURRENT.MARKET.DYNAMICS................................................................................................................................................ 4Fig.1: POC Diagnostics in Relation to the IVD Market, 2008 ...................................................................................................................................................................4Fig.2: Percentage of POC Diagnostics Market by Product, 2008 ............................................................................................................................................................5Fig.3: POC Diagnostics Market by Product, excl. Glucose, 2008 .............................................................................................................................................................6

Customers of POC Diagnostic Products ...............................................................................................................................6POC Technologies by Customer Segment ...............................................................................................................................................................................................7Fig.4: POC Diagnostics Market by Customer Type, 2008 ........................................................................................................................................................................8Fig.5: POC Diagnostics Self-Testing Market by Product Type, 2008 .......................................................................................................................................................8

Regional Perspective ............................................................................................................................................................8Fig.6: POC Diagnostics Market by Region, 2008 ..................................................................................................................................................................................10Fig.7: Professional POC Diagnostics Market by Region, 2008 ..............................................................................................................................................................10

Regulatory and Reimbursement Environment ................................................................................................................10CLIA.Waiver.........................................................................................................................................................................................11

COMPETITIVE.LANDSCAPE..................................................................................................................................................... 12Market Leaders by POC Product Type ...................................................................................................................................................................................................12Key POC Diagnostics Acquisitions, 2008-2009 .....................................................................................................................................................................................13

GROWTH.DRIVERS,.RESTRAINTS.AND.FUTURE.OPPORTUNITIES.................................................................................... 14POC Diagnostics as a Disruptive Technology ....................................................................................................................15Clinical Utility and Accuracy ...............................................................................................................................................15Connectivity .........................................................................................................................................................................16Future Technology: Next-Generation POC Diagnostic Products ....................................................................................17

Summary: Market Drivers, Restraints and Opportunities ...................................................................................................................................................................18MARKET.OUTLOOK.................................................................................................................................................................. 18

Global POC Diagnostics Market by Product Type, 2007-2014 (US$ million) ........................................................................................................................................19POC Diagnostics Market by Product Growth, 2008-2014 (%) .............................................................................................................................................................19Fig:8: Percentage of POC Diagnostics Market by Product, 2014E .........................................................................................................................................................20Fig.9: POC Diagnostics Market by Product, excl. Glucose, 2014E ..........................................................................................................................................................20

POC PRODUCTS AND TECHNOLOGIES ....................................................................................................... 21POC.BLOOD.GLUCOSE.TESTING.AND.DIABETES................................................................................................................. 21

WHO Diabetes Prevalence, 2000 and 2030 .........................................................................................................................................................................................22Blood Glucose Testing Market Dynamics ......................................................................................................................... 22

Leading Companies’ Diabetes Care Sales, 2004-2008 (US$ million) ...................................................................................................................................................22Fig.10: Global Blood Glucose Testing Market, 2005-2014E (US$ million) ............................................................................................................................................23Fig.11: Blood Glucose Testing Market by Customer Type, 2008 ............................................................................................................................................................23

Diabetes Self-Testing ......................................................................................................................................................... 23Conventional Blood Glucose Testing Products and Technologies ................................................................................. 25

FDA.Warning.-.GDH-PQQ.Test.Strips.............................................................................................................................................25Market-Leading Self-Testing Blood Glucose Meters ............................................................................................................................................................................27Competing Self-Testing Blood Glucose Meters .....................................................................................................................................................................................28New.Products.....................................................................................................................................................................................28

Abbott’s FreeStyle Lite and FreeStyle Freedom Lite ................................................................................................................................................................28Arkray’s Glucocard Blood Glucose Monitoring Systems ...........................................................................................................................................................29AgaMatrix’ WaveSense Products ..............................................................................................................................................................................................29Bayer’s Contour USB ...................................................................................................................................................................................................................29Bayer’s DIDGET Meter ................................................................................................................................................................................................................30Home Diagnostics ......................................................................................................................................................................................................................30

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Infopia’s Evolution ......................................................................................................................................................................................................................31LifeScan’s New OneTouch Products ...........................................................................................................................................................................................31Roche’s New Accu-Chek Products ............................................................................................................................................................................................32Standard Diagnostics’ SD Codefree ..........................................................................................................................................................................................33

Professional.Use.Products...............................................................................................................................................................33Abbott’s Precision PCx ..............................................................................................................................................................................................................33AgaMatrix’ KeyNote Pro ............................................................................................................................................................................................................33Arkray Assure Blood Glucose Testing Products .........................................................................................................................................................................33LifeScan’s SureStep Flexx and SureStep Hospital ....................................................................................................................................................................34Nova Biomedical’s StatStrip Glucose Monitor ...........................................................................................................................................................................34Quest Diagnostics’ HemoCue Blood Glucose Testing Systems .................................................................................................................................................34Roche’s Accu-Chek Inform II .....................................................................................................................................................................................................35Via Medical’s Via Blood Glucose Monitoring System ...............................................................................................................................................................35

Continuous Glucose Monitoring ........................................................................................................................................35Clinical.Trial.Results.-.Highlighting.Benefits.and.Drawbacks...................................................................................................36Reimbursement.Issues.....................................................................................................................................................................36CGM.Competitive.Landscape..........................................................................................................................................................37Medtronic’s.CGM.Systems...............................................................................................................................................................37

Paradigm Veo System ................................................................................................................................................................................................................37CGMS iPro Recorder....................................................................................................................................................................................................................38Guardian REAL-Time System .....................................................................................................................................................................................................38Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System .................................................................................................................38OneTouch UltraLink Meter .........................................................................................................................................................................................................39Clinical Trials ...............................................................................................................................................................................................................................39

DexCom’s.CGM.Systems...................................................................................................................................................................40Litigation with Abbott ...............................................................................................................................................................................................................40

Abbott’s.FreeStyle.Navigator.CGM.System..................................................................................................................................41ACON.Laboratories.On.Call.Plus.....................................................................................................................................................42A.Menarini.Diagnostics’.GlucoDay.S..............................................................................................................................................42CGM.Products.in.Development......................................................................................................................................................42

DexCom Products.......................................................................................................................................................................................................................42Medtronic ...................................................................................................................................................................................................................................43

Next-Generation Blood Glucose Testing ......................................................................................................................... 43OrSense’s.NBM-200G.Non-Invasive.Blood.Glucose.Meter........................................................................................................44Products.in.Development................................................................................................................................................................44

AiMedics’ HypoMon ..................................................................................................................................................................................................................44Calisto Medical’s Glucoband ......................................................................................................................................................................................................44Draper Laboratory’s Ion-Selective Quantum Dots ....................................................................................................................................................................45Echo Therapeutics’ Symphony tCGM System ...........................................................................................................................................................................45Freedom Meditech’s Non-Invasive Technology ........................................................................................................................................................................47Integrity Applications’ GlucoTrack .............................................................................................................................................................................................47Lein Applied Diagnostics ...........................................................................................................................................................................................................48LighTouch Medical Technology .................................................................................................................................................................................................48MicroCHIPS .................................................................................................................................................................................................................................48Oxygen Biotherapeutics/Glucometrics .....................................................................................................................................................................................49Sensors for Medicine & Science’s SMSI Glucose Sensor ............................................................................................................................................................49Solianis Monitoring’s Non-Invasive Continuous Glucose Monitor ...........................................................................................................................................49VeraLight’s SCOUT DS ................................................................................................................................................................................................................50

Other Blood Glucose Products in Development ...............................................................................................................51GluMetrics’.GluCath.Intravascular.CGM........................................................................................................................................51Luminous.Medical’s.Automated.Blood.Glucose.Monitor..........................................................................................................52

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HbA1c Testing ......................................................................................................................................................................52HbA1c.Products.................................................................................................................................................................................53

ApexBio’s A1C Express ................................................................................................................................................................................................................53Arkray’s ADAMS A1c HA-8160 ....................................................................................................................................................................................................53Axis-Shield’s Afinion HbA1c and NycoCard HbA1c Tests ...........................................................................................................................................................53Bayer’s A1CNow Products ..........................................................................................................................................................................................................53Bio-Rad’s in2it A1C Analyser .....................................................................................................................................................................................................54DiaSys Diagnostic Systems’ InnovaStar .....................................................................................................................................................................................54Hubit’s LabonaCare HbA1c ........................................................................................................................................................................................................54Infopia’s Easy/Clover A1c ............................................................................................................................................................................................................54Inverness Medical Innovations’ Cholestech GDX ......................................................................................................................................................................54MEC Dynamics’ Avie A1c HbA1c System ....................................................................................................................................................................................54Quotient Diagnostics’ Quo-Test .................................................................................................................................................................................................55Siemens’ DCA Vantage Analyser ...............................................................................................................................................................................................55TOSOH Bioscience’s G7 and G8 HbA1c Analysers ......................................................................................................................................................................55In Development .........................................................................................................................................................................................................................55

Ketone Testing .................................................................................................................................................................... 56POC.MULTI-FUNCTIONAL.CLINICAL.CHEMISTRY.ANALYSERS..........................................................................................56

Abaxis’ Piccolo xpress ........................................................................................................................................................ 56Abbott’s i-STAT POC Products ............................................................................................................................................57Audit Diagnostics’ Liqui-Stat Wet Chemistry POC System ............................................................................................. 58Arkray’s SpotChem EZ Dry Chemistry Analyser and SpotChem D-Concept ................................................................. 58Axis-Shield’s Afinion POC System ..................................................................................................................................... 58Axis-Shield’s NycoCard System ......................................................................................................................................... 59Horiba ABX’ ABX Pentra 400 Clinical Chemistry Analyser .............................................................................................. 60MagnaBioSciences’ MICT ................................................................................................................................................... 60Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System ...................................................................................... 60Probe Scientific MicroEye Blood Analysis Device .............................................................................................................61Radiometer’s AQT90 FLEX Immunoassay Analyser ..........................................................................................................61ReLIA Diagnostic Systems’ ReLIA System ......................................................................................................................... 62TOSOH Bioscience’s AIA-360 System ................................................................................................................................ 62Wako Diagnostics’ APOLOWAKO Point-of-Care Analyzer .............................................................................................. 62

In.Development.................................................................................................................................................................................63Claros Diagnostics’ Claros System .............................................................................................................................................................................................63DxTech’s Vantix System ..............................................................................................................................................................................................................63

POC.CARDIOVASCULAR.TESTING..........................................................................................................................................64POC Coagulation Testing ................................................................................................................................................... 64

Market.Dynamics..............................................................................................................................................................................65Fig.12: Global POC Coagulation Market, 2007-2014E (US$ million) .....................................................................................................................................................65Self-Monitoring.................................................................................................................................................................................66

Inverness Medical Innovations’ HemoSense INRatio System and CoagCare ...........................................................................................................................66International Technidyne Corporation’s ProTime Microcoagulation System ..........................................................................................................................67Roche’s CoaguChek XS ..............................................................................................................................................................................................................67

Professional.Use.Products...............................................................................................................................................................67Axis-Shield Products ..................................................................................................................................................................................................................68Helena Laboratories’ Cascade POC System ...............................................................................................................................................................................68Medtronic‘s ACT Plus Automated Coagulation Timer System .................................................................................................................................................69Instrumentation Laboratory’s GEM PCL Plus ............................................................................................................................................................................69International Technidyne Corporation’s Hemochron Whole Blood Coagulation System .......................................................................................................69Roche’s CoaguChek Systems ......................................................................................................................................................................................................70

Cardiac Markers ...................................................................................................................................................................70

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POC.Testing........................................................................................................................................................................................71Fig.13: Global POC Cardiac Marker Testing Market, 2007-2014E (US$ million)....................................................................................................................................72POC.Testing.Products.......................................................................................................................................................................73Currently-Available Cardiac Marker POC Tests .....................................................................................................................................................................................73

bioMérieux VIDAS Emergency Care Products ........................................................................................................................................................................... 74DxCon POC Cardiovascular Tests ................................................................................................................................................................................................ 74Inverness Medical Innovations’ Triage and Clearview Products ..............................................................................................................................................75Princeton BioMeditech/LifeSign’s StatusFirst Tests and DXpress Reader ................................................................................................................................76Mitsubishi Chemical’s Pathfast Immunoassay Analyzer ..........................................................................................................................................................76Response Biomedical’s RAMP 200 Platform .............................................................................................................................................................................76Roche Cardiac Testing Products ................................................................................................................................................................................................77Siemens’ Stratus CS Analyzer ....................................................................................................................................................................................................77

Cholesterol Testing ............................................................................................................................................................ 78Home.Testing.....................................................................................................................................................................................78

Chematics Chemcard Cholesterol Test ......................................................................................................................................................................................78Infopia’s Lipid Pro .......................................................................................................................................................................................................................79Inverness Medical Innovations’ First Check Cholesterol Test ...................................................................................................................................................79Roche’s Accutrend Plus .............................................................................................................................................................................................................79Syntron Bioresearch’s Venture Total Cholesterol Test ..............................................................................................................................................................79In Development .........................................................................................................................................................................................................................79

Professional.Use.Products...............................................................................................................................................................79Inverness Medical Innovations’ Cholestech LDX System .........................................................................................................................................................80Polymer Technology Systems’ CardioChek ...............................................................................................................................................................................80PreMD’s PREVU Point of Care Skin Sterol Test ...........................................................................................................................................................................80

POC.HAEMATOLOGY.AND.HAEMOSTASIS.PRODUCTS...................................................................................................... 82Haematology Analysers ..................................................................................................................................................... 82

Beckman.Coulter’s.COULTER.AC•T.Series......................................................................................................................................82Chempaq’s.POC.Haematology.Analysers.....................................................................................................................................82Quest.Diagnostics’.HemoCue.White.Blood.Cell.Analyzer.........................................................................................................83Horiba.ABX’.Haematology.Analysers............................................................................................................................................83

ABX Micros ES60.........................................................................................................................................................................................................................83ABX Micros 60.............................................................................................................................................................................................................................83ABX Micros CRP 200 ...................................................................................................................................................................................................................84ABX Pentra 60C+ .......................................................................................................................................................................................................................84

Symex’.Haematology.Analysers.....................................................................................................................................................84Arkray’s PocketChem BA Blood Ammonia Meters .......................................................................................................... 84Arkray’s Lactate Pro LT-1710 Blood Lactate Test Meter .................................................................................................. 85Haemoglobin Systems ....................................................................................................................................................... 85

ApexBio’s.HemoSmart.Haemoglobin.Screening.System..........................................................................................................85Audit.Diagnostics’.Hb-Stat..............................................................................................................................................................85International.Technidyne’s.Hgb.Pro.Professional.Hemoglobin.Testing.System..................................................................85Quest.Diagnostics’.HemoCue.Haemoglobin.Systems...............................................................................................................85

HemoCue 201 DM Analyser Whole Blood Systems ..................................................................................................................................................................86Stanbio.Laboratory’s.HemoPoint.H2.and.STAT-Site.M.Hgb......................................................................................................86URIT.Medical’s.HemoTest.Hemoglobin.Meter.............................................................................................................................87

Coagulation, Platelet Function and Haemostasis ........................................................................................................... 87Platelet.Function.Assessment.........................................................................................................................................................87

Accumetrics’ VerifyNow System ...............................................................................................................................................................................................87Akers Biosciences’ PIFA Heparin/PF4 Rapid Assay ....................................................................................................................................................................88DiaMed’s Impact Analyzer .......................................................................................................................................................................................................89Haemonetics’ TEG Thrombelastograph Hemostasis Analyzer .................................................................................................................................................89

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Helena Laboratories’ Plateletworks System .............................................................................................................................................................................89Medtronic’s HMS PLUS Haemostasis Management System ....................................................................................................................................................89Pentapharm’s ROTEM Systems ..................................................................................................................................................................................................89Siemens’ PFA-100 Platelet Function Analyser ..........................................................................................................................................................................90Sienco’s Sonoclot Coagulation & Platelet Function Analyzers .................................................................................................................................................90

POC.BLOOD.GAS/ELECTROLYTE.ANALYSERS...................................................................................................................... 91Mayo Clinic’s Estimated Glomerular Filtration Rate Study..............................................................................................91Arkray’s SpotChem EL Electrolyte Analyser ......................................................................................................................92Epocal’s epoc ........................................................................................................................................................................92Instrumentation Laboratory’s POC Critical Care Diagnostics .........................................................................................92

Synthesis.Blood.Gas.Analysers.......................................................................................................................................................93International Technidyne’s IRMA TRUpoint Blood Analysis System ............................................................................. 93International Technidyne Corporation’s AVOXimeter Products .................................................................................... 93Nova Biomedical’s Products .............................................................................................................................................. 94

Statsensor.Creatinine.Meter...........................................................................................................................................................94Stat.Profile.Critical.Care.Xpress.......................................................................................................................................................94

Stat Profile pHOx .......................................................................................................................................................................................................................95Nova.Biomedical.Electrolyte/Chemistry.Analysers....................................................................................................................95Patient.Data.Manager.(PDM)..........................................................................................................................................................95

OPTI Medical Systems’ Products ....................................................................................................................................... 96OrSense’s NBM-200MP Multi-Parameter Sensor ............................................................................................................ 96

Clinical Trial Results ...................................................................................................................................................................................................................97Radiometer’s Blood Gas Analysers ................................................................................................................................... 97

1st.automatic.....................................................................................................................................................................................97ABL80.FLEX.........................................................................................................................................................................................98ABL800.FLEX......................................................................................................................................................................................98ABL77...................................................................................................................................................................................................98ABL5.....................................................................................................................................................................................................98NPT7....................................................................................................................................................................................................98

Roche’s cobas Blood Gas Analysers .................................................................................................................................. 98Siemens’.Blood.Gas.Analyser.Range.............................................................................................................................................99RAPIDPoint.340/350.Blood.Gas.Systems......................................................................................................................................99RAPIDPoint.400.Series.....................................................................................................................................................................99RapidComm.......................................................................................................................................................................................99Via.Medical’s.Products.................................................................................................................................................................. 100

POC.INFECTIOUS.DISEASE.TESTS........................................................................................................................................100Fig.14: Global POC Infectious Disease Testing Market, 2007-2014E (US$ million) .............................................................................................................................101

POC Influenza Testing .......................................................................................................................................................101Performance.and.Use.of.Rapid.Influenza.Tests.in.the.US........................................................................................................102Flu.Detection.Products...................................................................................................................................................................103

3M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay..............................................................................................................................................103Arkray’s SPOTCHEM IL SL-4720 ...............................................................................................................................................................................................103Becton Dickinson’s Directigen EZ Flu A+B test .......................................................................................................................................................................104Genzyme Diagnostics’ OSOM Influenza A & B Test .................................................................................................................................................................104Inverness Medical Innovations’ BinaxNOW Influenza A&B Test ............................................................................................................................................104Inverness Medical Innovations’ Clearview Exact Influenza A & B ..........................................................................................................................................104Medix Biochemica’s Actim Influenza A&B ..............................................................................................................................................................................104Meridian Bioscience’s TRU FLU ................................................................................................................................................................................................105Quidel’s QuickVue Influenza Tests ...........................................................................................................................................................................................105Remel’s Xpect Flu A&B .............................................................................................................................................................................................................105SA Scientific’s SAS FluAlert ......................................................................................................................................................................................................105

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Sysmex’ POCTEM Influenza A/B ..............................................................................................................................................................................................105Products.in.Development..............................................................................................................................................................106

Chembio’s DPP Influenza ........................................................................................................................................................................................................106DxCon/HX Diagnostics’ fluID and panfluID Rapid Influenza Test ...........................................................................................................................................106GlaxoSmithKline and Enigma Diagnostics .............................................................................................................................................................................106Meso Scale Diagnostics’ MSD Point of Care Influenza Test ....................................................................................................................................................107Sysmex’ Avian Influenza Test ..................................................................................................................................................................................................107

Respiratory Syncytial Virus ............................................................................................................................................. 1073M.Rapid.Detection.RSV.Test........................................................................................................................................................108

Group A Streptococcus Tests ........................................................................................................................................... 109Currently Available POC Tests .............................................................................................................................................................................................................109

POC HIV Testing .................................................................................................................................................................110HIV Prevalence by Region, 2007 ......................................................................................................................................................................................................... 111Market.Dynamics............................................................................................................................................................................ 111Currently-Available.Products.......................................................................................................................................................112

Ani Biotech’s Biocard HIV (1+2) ............................................................................................................................................................................................... 112AT First Diagnostic’s FirstVue HIV Tests ................................................................................................................................................................................... 112bioLytical Laboratories’ INSTI Kit ............................................................................................................................................................................................. 112BioMérieux’ VIKIA HIV1/2 HIV Test .......................................................................................................................................................................................... 113Bio-Rad’s Multispot HIV-1/HIV-2 Rapid Test ........................................................................................................................................................................... 113Calypte Biomedical’s Aware HIV-1/2 Tests .............................................................................................................................................................................. 113Chembio Diagnostics SURE CHECK HIV 1/2/Clearview Complete HIV 1/2 ............................................................................................................................. 114EY Laboratories’ InstantCHEK .................................................................................................................................................................................................. 115Hema Diagnostic Systems ....................................................................................................................................................................................................... 115IND Diagnostic’s One-Step Anti-HIV (1+2) Tests ..................................................................................................................................................................... 115Inverness Medical Innovations’ Determine and Clearview .................................................................................................................................................... 115MedMira’s Tests........................................................................................................................................................................................................................ 116OraSure’s OraQuick ADVANCE HIV-1/2 .................................................................................................................................................................................... 116Trinity Biotech’s POC HIV Tests ................................................................................................................................................................................................. 117Savyon Diagnostics’ HIVSav 1/2/0 Rapid SeroTest ................................................................................................................................................................. 118Standard Diagnostics’ SD BIOLINE HIV-1/2 3.0 ........................................................................................................................................................................ 118

Products.in.Development..............................................................................................................................................................118Calypte Biomedical .................................................................................................................................................................................................................. 118Chembio’s DPP HIV 1/2 Screening Assay ................................................................................................................................................................................. 119OraSure’s OraQuick HIV OTC Test ............................................................................................................................................................................................. 119Inverness Medical Innovations’ pima Point-of-Care CD4 Instrument .................................................................................................................................. 119Inverness Medical Innovations’ Clondiag HIV Molecular Device ............................................................................................................................................120

POC Hepatitis Tests............................................................................................................................................................120Hepatitis.B.........................................................................................................................................................................................120Hepatitis.C........................................................................................................................................................................................121Available.Tests.................................................................................................................................................................................121

Alfa Scientific Designs’ Instant-View Tests ............................................................................................................................................................................. 121AT First Diagnostic FirstVue Rapid Test Kit ............................................................................................................................................................................. 121BioMérieux‘ VIKIA HBs Ag Hepatitis B Test .............................................................................................................................................................................122MedMira’s MiraWell Rapid HBV and HCV Tests ......................................................................................................................................................................122Runbio Biotech’s One Step Tests ..............................................................................................................................................................................................123YD Diagnostics’ HepaScan Tests .............................................................................................................................................................................................123

In.Development...............................................................................................................................................................................123OraSure Technologies’ OraQuick HCV Test .............................................................................................................................................................................123

MedMira’s Multiplo Combination HIV/Hepatitis Tests ..................................................................................................124H. pylori Tests .....................................................................................................................................................................124

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Currently Available H. pylori Tests ......................................................................................................................................................................................................125Exalenz.Bioscience’s.BreathID.System........................................................................................................................................125Meretek.Diagnostics’.BreathTek.UBT..........................................................................................................................................126

Mononucleosis Tests .........................................................................................................................................................126Currently Available POC Tests .............................................................................................................................................................................................................126

Hema Diagnostic Systems’ Rapid 1-2-3 Hema TB Test ...................................................................................................127Tropical Disease Tests .......................................................................................................................................................127

Akers.Bioscience..............................................................................................................................................................................127Ani.Biotech’s.BIOCARD.Malaria....................................................................................................................................................127Hema.Diagnostic.Systems’.Malaria.Tests...................................................................................................................................127Quest.Diagnostics’.Focus.Dengue.Rapid.Tests..........................................................................................................................127New.Horizons.Diagnostic’s.Cholera.SMART...............................................................................................................................128

Sexually-Transmitted Diseases and Related Diagnostics ..............................................................................................128Ani.Biotech’s.Biocard.Candida.and.Trichomonas.Tests...........................................................................................................128AT.First.Diagnostic’s.inSTIcheck...................................................................................................................................................128Focus.Diagnostics’.HerpeSelect.Express.HSV-2.........................................................................................................................129Genzyme’s.OSOM.Trichomonas.and.OSOM.BVBLUE.Test........................................................................................................129Gryphus.Diagnostics’.BVBLUE......................................................................................................................................................129Hema.Diagnostic.Systems’.Rapid.1-2-3.Hema.Syphilis............................................................................................................130MagnaBioSciences.MICT.Chlamydia.Test...................................................................................................................................130Quidel.Reproductive.and.Women’s.Health................................................................................................................................130Runbio.Biotech’s.Tests....................................................................................................................................................................130Savyon.Diagnostics’.SavvyCheck.................................................................................................................................................130

Rotavirus and Adenoviral Enteritis Tests ........................................................................................................................131Ani.Biotech’s.Biocard.Tests............................................................................................................................................................131Meridian.Bioscience.ImmunoCard.STAT!.Rotavirus..................................................................................................................131Orion.Diagnostica’s.Diarlex,.Rotalex.and.Adenolex.Tests.......................................................................................................131

Trinity Biotech’s Uni-Gold Legionella Urinary Antigen .................................................................................................131Ani Biotech’s MySet ...........................................................................................................................................................131Products in Development ................................................................................................................................................132

Chembio.Diagnostics’.DPP.Platform...........................................................................................................................................132DPP Syphilis Screen & Confirm ................................................................................................................................................................................................ 132DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests ..................................................................................................................................... 133DPP Leptospirosis .................................................................................................................................................................................................................... 133Visceral Leishmaniasis Disease Research Institute ................................................................................................................................................................. 133Work with Oswaldo Cruz Foundation ....................................................................................................................................................................................134

MedMira............................................................................................................................................................................................134Tyrian.Diagnostics’.DiagnostIQ.for.TB.........................................................................................................................................134

POC.C-REACTIVE.PROTEIN.DIAGNOSTICS.......................................................................................................................... 135Abaxis’ MetLyte Plus CRP ..................................................................................................................................................136Arkray’s SPOTCHEM IL SL-4720 ........................................................................................................................................136Axis-Shield .........................................................................................................................................................................136LifeAssays’ CRP and hsCR ..................................................................................................................................................137Medix Biochemica’s Actim CRP ........................................................................................................................................137Orion Diagnostica’s QuikRead System ............................................................................................................................137

POC.CANCER.DIAGNOSTICS................................................................................................................................................. 137Fig.15: Global POC Cancer Testing Market, 2007-2014E (US$ million) ...............................................................................................................................................138

Prostate Specific Antigen Tests ........................................................................................................................................138Market.Dynamics............................................................................................................................................................................139

Mediwatch’s PSAwatch ...........................................................................................................................................................................................................140Recall of PSA POC Tests ...........................................................................................................................................................................................................140

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Occult Blood Testing ........................................................................................................................................................ 140Aerscher.Diagnostics’.HemaPrompt...........................................................................................................................................141Beckman.Coulter’s.Hemoccult.Tests............................................................................................................................................141Biomerica’s.EZ.Detect.....................................................................................................................................................................141Helena.Laboratories’.ColoCare.....................................................................................................................................................141Immunostics’.Hema-Screen..........................................................................................................................................................142Inverness.Medical.Innovations’.Tests..........................................................................................................................................142Orion.Diagnostica’s.QuikRead.System........................................................................................................................................142Quest.Diagnostics’.InSure.Quik.F.I.T............................................................................................................................................142Quidel’s.QuickVue.iFOB..................................................................................................................................................................143Other.Available.FOB.Tests..............................................................................................................................................................144Gastric.Occult.Blood.Tests.............................................................................................................................................................144

CEA Testing .........................................................................................................................................................................145Alpha Fetoprotein Testing ................................................................................................................................................145Bladder Cancer Testing .....................................................................................................................................................145

Inverness.Medical.Innovations’.Matritech.NMP22.BladderChek.Test..................................................................................146Mediwatch’s.Bladderwatch.BTA.Test...........................................................................................................................................146

Novel Products in Development ..................................................................................................................................... 146Akers.Biosciences’.Breath.PulmoHealth.Check.........................................................................................................................146Balter.Medical’s.Optical.Transfer.Diagnosis.Platform..............................................................................................................146Guided.Therapeutics’.LightTouch.Cervical.Cancer.Detection.Device...................................................................................147

Lung and Oesophageal Cancer ................................................................................................................................................................................................148MASCOT.Project’s.Lab-on-a-Chip.for.Breast.Cancer.Detection.............................................................................................148

POC.URINALYSIS.....................................................................................................................................................................149Fig.16: Global POC Urinalysis Market, 2007-2014E (US$ million).......................................................................................................................................................150Currently-Available Urine Analysis Test Strips ...................................................................................................................................................................................150

Key Products ......................................................................................................................................................................151ACON.Laboratories’.Mission.Products........................................................................................................................................151Arkray’s.Products............................................................................................................................................................................151

PocketChem UA ........................................................................................................................................................................................................................ 151AUTION ELEVEN ........................................................................................................................................................................................................................ 151DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips for Urinalysis .......................................................................................................... 151

Roche’s.Products.............................................................................................................................................................................152Urisys 1100 Urine Analyser ......................................................................................................................................................................................................152Chemstrip Criterion II Analyzer................................................................................................................................................................................................152

Siemens’.Products...........................................................................................................................................................................152Clinitek Advantus Analyzer ......................................................................................................................................................................................................152Clinitek Status Analyser ...........................................................................................................................................................................................................152Multistix10 SG Reagent Strips .................................................................................................................................................................................................152

Urinary Tract Infection Tests.............................................................................................................................................153ACON.Laboratories’.Mission.UTI.Urinary.Tract.Infection.Test.Strips.....................................................................................153Jant.Pharmacal’s.Accutest.Uriscreen.Rapid.UTI.Screen.Test...................................................................................................153Orion.Diagnostica’s.Uricult.Dipslide.Tests..................................................................................................................................153

Microalbumin Testing .......................................................................................................................................................153Axis-Shield’s.Afinion.ACR.Test......................................................................................................................................................154Biomerica’s.Fortel.Urine.Albumin.Test........................................................................................................................................154Genzyme’s.OSOM.ImmunoDip.Urinary.Albumin.Test.............................................................................................................154Orion.Diagnostica’s.QuikRead.U-ALB..........................................................................................................................................154Quest.Diagnostics’.HemoCue.Albumin.201.System.................................................................................................................154Siemens’.Clinitek.Microalbumin.Strips.......................................................................................................................................155

POC.FERTILITY.AND.PREGNANCY.TESTING....................................................................................................................... 155

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Fig.17: Global POC Pregnancy & Fertility Market, 2007-2014E (US$ million) ....................................................................................................................................155Competitive Landscape - Pregnancy Testing Kits ..........................................................................................................156

Inverness.Medical’s.US.Federal.Trade.Commission.Settlement.Agreement.......................................................................157Competitive Landscape - Ovulation Testing Kits .......................................................................................................... 158Competitive Landscape - Menopause Testing Kits ....................................................................................................... 158SPD Swiss Precision Diagnostics’ Consumer Products ..................................................................................................159Labour and Delivery Testing ........................................................................................................................................... 160

Amnisure.International’s.AmniSure.PROM.Tests......................................................................................................................160Medix.Biochemica’s.Actim.PROM.and.Actim.Partus................................................................................................................161

POC.DRUGS.OF.ABUSE.TESTING.......................................................................................................................................... 161Market Dynamics .............................................................................................................................................................. 162

Currently-Available POC Drugs of Abuse Testing Products ................................................................................................................................................................162DoA.Product.Highlights.................................................................................................................................................................163

Alfa Scientific Designs’ Drug Screen Tests ...............................................................................................................................................................................163American Bio Medica’s Drug Abuse Tests ...............................................................................................................................................................................164Inverness Medical Innovations’ Tests ......................................................................................................................................................................................165Phamatech Drugs of Abuse Tests ............................................................................................................................................................................................166

Products.in.Development..............................................................................................................................................................166Concateno and Philips Alliance................................................................................................................................................................................................166

Alcohol.Testing................................................................................................................................................................................167ACON Laboratories' Alcohol Testing Products.........................................................................................................................................................................167Akers Biosciences’ BreathScan ................................................................................................................................................................................................167Chematics’ Alco-Screen ...........................................................................................................................................................................................................167Inverness Medical Innovations’ Products ...............................................................................................................................................................................167OraSure’s Q.E.D. Saliva Alcohol Test .........................................................................................................................................................................................168

OTHER.POC.PRODUCTS.........................................................................................................................................................168Thyroid Tests ..................................................................................................................................................................... 168

Screening.Devices.Canada’s.ThyroChek.....................................................................................................................................168Ani Biotech’s Biocard Coeliac Tests ................................................................................................................................. 168BioMérieux’ VIDAS B·R·A·H·M·S PCT Test ....................................................................................................................... 169Exalenz Bioscience’s BreathID System ........................................................................................................................... 169Inverness Medical Innovations’ Triage NGAL Test ......................................................................................................... 169Magellan Biosciences’ LeadCare II System......................................................................................................................170

EMERGING.TECHNOLOGIES................................................................................................................................................. 170Amic (Johnson & Johnson) ................................................................................................................................................171Atlas Genetics’ Velox .........................................................................................................................................................171Atonomics’ Atolyzer ..........................................................................................................................................................172Cepheid’s GeneXpert ........................................................................................................................................................172Draper Laboratory and Sionex ........................................................................................................................................173Enigma Diagnostics’ PRADA .............................................................................................................................................174IQuum’s Liat System ..........................................................................................................................................................174MASCOT Project’s Lab-on-a-Chip for Breast Cancer Detection.....................................................................................175Molecular Vision ...............................................................................................................................................................175MycroLab ............................................................................................................................................................................176Philips’ Magnotech ............................................................................................................................................................176T2 Biosystems ...................................................................................................................................................................177US Naval Research Laboratory’s cBASS ...........................................................................................................................178

POC MANUFACTURERS ............................................................................................................................. 179POC.COMPANY.DIRECTORY.................................................................................................................................................. 179LEADING.COMPANY.PROFILES............................................................................................................................................189

Abaxis ................................................................................................................................................................................ 189

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Piccolo.xpress...................................................................................................................................................................................189Current.Alliances.............................................................................................................................................................................190

Distribution Partners ...............................................................................................................................................................................................................190bioMérieux SA ..........................................................................................................................................................................................................................190

Financial.Performance...................................................................................................................................................................190Abaxis - Operating Results, 2005-2009 (US$ million) .......................................................................................................................................................................191

Latest Results ........................................................................................................................................................................................................................... 191Abbott ................................................................................................................................................................................192

Diabetes.Care...................................................................................................................................................................................192FreeStyle Blood Glucose Monitoring Products ....................................................................................................................................................................... 192Precision Xceed (Optium Xceed) Advanced Diabetes Management System ......................................................................................................................... 193Precision Xtra Advanced Diabetes Management System ...................................................................................................................................................... 193FreeStyle CoPilot Health Management System ...................................................................................................................................................................... 193Precision PCx ...........................................................................................................................................................................................................................194QC Manager ..............................................................................................................................................................................................................................194

i-STAT.Point-of-Care.Products.......................................................................................................................................................194i-STAT System ...........................................................................................................................................................................................................................194Cartridges .................................................................................................................................................................................................................................194

Current.Alliances.............................................................................................................................................................................195Axis-Shield ................................................................................................................................................................................................................................195Calypte Biomedical ..................................................................................................................................................................................................................195

Litigation...........................................................................................................................................................................................195Nova Biomedical ......................................................................................................................................................................................................................195Church & Dwight ......................................................................................................................................................................................................................195DexCom ...................................................................................................................................................................................................................................196Becton Dickinson .....................................................................................................................................................................................................................196

Financial.Performance...................................................................................................................................................................197Abbott Diagnostics Sales, 2005-2008 (US$ million) ..........................................................................................................................................................................197Fig.18: Percentage of Abbott Diagnostics Revenue by Region, 2008 .................................................................................................................................................197Abbott Diabetes Care Sales by Region, 2005-2008 (US$ million) ......................................................................................................................................................198Fig.19: Percentage of Abbott Diabetes Care Revenue by Region, 2008 .............................................................................................................................................198

Latest Results ...........................................................................................................................................................................................................................198Accumetrics ...................................................................................................................................................................... 199

Fig.20: Accumetrics Revenue by Segment, 2005-2008 (US$ thousands) ..........................................................................................................................................199VerifyNow System ............................................................................................................................................................ 199Distribution Agreements ................................................................................................................................................. 200ACON Laboratories ........................................................................................................................................................... 201

On.Call.Plus.Blood.Glucose.Monitoring.System........................................................................................................................201Mission.Urinalysis.Products...........................................................................................................................................................201

Test Strips .................................................................................................................................................................................................................................201Urine Analysers ........................................................................................................................................................................................................................201

Alcohol.Testing................................................................................................................................................................................202Akers Biosciences ............................................................................................................................................................. 203

Recent Key Events ...............................................................................................................................................................................................................................203Current.Products............................................................................................................................................................................ 204

PIFA Heparin/PF4 Rapid Assay ................................................................................................................................................................................................204BreathScan ...............................................................................................................................................................................................................................204Non Core Products ...................................................................................................................................................................................................................204

Research.and.Development......................................................................................................................................................... 204Tri-Cholesterol Check ...............................................................................................................................................................................................................204Breath Ketone Check ................................................................................................................................................................................................................205

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Breath PulmoHealth Check .....................................................................................................................................................................................................205BreathScan PRO .......................................................................................................................................................................................................................205

Current.Alliances............................................................................................................................................................................ 206AFRICA Continental Holdings ..................................................................................................................................................................................................206PULSE Health ............................................................................................................................................................................................................................206Inverness Medical Innovations ................................................................................................................................................................................................206Trinity Biotech, Corgenix and Cardinal Health ........................................................................................................................................................................206

Financial.Performance.................................................................................................................................................................. 206Akers Biosciences Operating Results, 2004-2008 (US$ thousands) ...................................................................................................................................................207

Latest Results ...........................................................................................................................................................................................................................207Fig.21: Akers Biosciences - Revenue by Product, H1 2009 ..................................................................................................................................................................207

American Bio Medica ....................................................................................................................................................... 208Recent Key Events ...............................................................................................................................................................................................................................208Drug.Abuse.Tests............................................................................................................................................................................ 208

Urine Tests ................................................................................................................................................................................................................................208Saliva Tests ...............................................................................................................................................................................................................................209Rapid Reader ............................................................................................................................................................................................................................210Adulteration, Alcohol and Nicotine Products .........................................................................................................................................................................210

Current.Alliances.............................................................................................................................................................................210Hema Diagnostic Systems .......................................................................................................................................................................................................210

Financial.Performance...................................................................................................................................................................210American Bio Medical Operating Results, 2004-2008 (US$ millions) ............................................................................................................................................... 211

Latest Results ........................................................................................................................................................................................................................... 211Arkray .................................................................................................................................................................................212

Recent Key Events ............................................................................................................................................................................................................................... 212SPOTCHEM.IL.SL-4720.....................................................................................................................................................................212SpotChem.EZ.Dry.Chemistry.Analyser.and.SpotChem.D-Concept.......................................................................................213SpotChem.EL.Electrolyte.Analyser..............................................................................................................................................213PocketChem.BA.Blood.Ammonia.Meters...................................................................................................................................213Lactate.Pro.LT-1710.Blood.Lactate.Test.Meter...........................................................................................................................214Urinalysis...........................................................................................................................................................................................214

PocketChem UA ........................................................................................................................................................................................................................ 214AUTION ELEVEN ........................................................................................................................................................................................................................ 214DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips for Urinalysis .......................................................................................................... 214

Blood.Glucose.Self-Testing............................................................................................................................................................214Glucocard Meters .................................................................................................................................................................................................................... 214Assure Blood Glucose Testing Products .................................................................................................................................................................................. 215

Current.Alliances.............................................................................................................................................................................215ELITech Group ........................................................................................................................................................................................................................... 215Nipro ......................................................................................................................................................................................................................................... 215MyCareTeam ............................................................................................................................................................................................................................ 216A Menarini Diagnostics ............................................................................................................................................................................................................ 216

Axis-Shield .........................................................................................................................................................................217Recent Key Events ...............................................................................................................................................................................................................................218Afinion.POC.System........................................................................................................................................................................218NycoCard...........................................................................................................................................................................................219Coagulation.Products.....................................................................................................................................................................219

Thrombotrack Coagulometers ................................................................................................................................................................................................ 219Thrombotest (PT-INR) ..............................................................................................................................................................................................................220Nycotest PT (INR)......................................................................................................................................................................................................................220

Current.Alliances............................................................................................................................................................................ 220

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Abbott and PSS World Medical ...............................................................................................................................................................................................220ITI Techmedia (Biosensor Platform for Theranostic Applications) .........................................................................................................................................220

Financial.Performance...................................................................................................................................................................221Fig.22: Axis-Shield Revenue by Business, 2008 ..................................................................................................................................................................................221Fig.23: Axis-Shield Revenue by Region, 2008 ....................................................................................................................................................................................222Axis-Shield - POC Segment Operating Results, 2004-2008 (£ million) ..............................................................................................................................................222Axis-Shield - POC Sales by Product Line, 2004-2008 (£ million) ........................................................................................................................................................222Fig.24: Axis-Shield POC Sales by Product, 2008 .................................................................................................................................................................................223

Latest Results ...........................................................................................................................................................................................................................223Bayer .................................................................................................................................................................................. 224

Ascensia.Blood.Glucose.Monitoring.Systems............................................................................................................................224Contour USB .............................................................................................................................................................................................................................225DIDGET Meter ...........................................................................................................................................................................................................................225

A1CNow.Products........................................................................................................................................................................... 225Current.Alliances............................................................................................................................................................................ 226

Medtronic .................................................................................................................................................................................................................................226Echo Therapeutics ....................................................................................................................................................................................................................226

Financial.Performance.................................................................................................................................................................. 226Fig.25: Bayer Diabetes Care Revenue, 2005-2008 (EUR million) .......................................................................................................................................................227Bayer Diabetes Care Revenue by Type, 2005-2008 (EUR million) ......................................................................................................................................................227

Beckman Coulter .............................................................................................................................................................. 228Rapid.Tests....................................................................................................................................................................................... 228

Hemoccult Tests ......................................................................................................................................................................................................................228Gastroccult ...............................................................................................................................................................................................................................228

Haematology.Analysers................................................................................................................................................................ 228Biomerica .......................................................................................................................................................................... 230

Home.Diagnostic.Products.......................................................................................................................................................... 230Fortel Urine Albumin Test ........................................................................................................................................................................................................230

Professional.Use.Products.............................................................................................................................................................231Financial.Performance...................................................................................................................................................................231Biomerica - Operating Results, 2005-2009 (US$ thousand) .............................................................................................................................................................232Biomerica - Revenue by Region, 2008-2009 (US$ thousand) ...........................................................................................................................................................232Fig.26: Percentage of Biomerica’s Revenue by Region, 2009 .............................................................................................................................................................233

Latest Results ...........................................................................................................................................................................................................................233bioMérieux ........................................................................................................................................................................ 234

Emergency.Care............................................................................................................................................................................. 234VIDAS NT-proBNP ....................................................................................................................................................................................................................234VIDAS D-Dimer Exclusion .........................................................................................................................................................................................................234VIDAS Tropinin I Ultra ...............................................................................................................................................................................................................235VIDAS B·R·A·H·M·S PCT. Test .....................................................................................................................................................................................................235

Rapid.Infectious.Disease.Tests..................................................................................................................................................... 235VIKIA HIV1/2 HIV Test ...............................................................................................................................................................................................................235VIKIA HBs Ag Hepatitis B Test ..................................................................................................................................................................................................235

Current.Alliances............................................................................................................................................................................ 236Quidel .......................................................................................................................................................................................................................................236Sysmex .....................................................................................................................................................................................................................................236Abaxis .......................................................................................................................................................................................................................................236ReLIA Diagnostic Systems ........................................................................................................................................................................................................236Roche Diagnostics ....................................................................................................................................................................................................................236Brahms .....................................................................................................................................................................................................................................236

Financial.Performance.................................................................................................................................................................. 236

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bioMérieux - Operating Results, 2006-2008 (EUR million) ...............................................................................................................................................................237Fig.27: Percentage of bioMérieux’ Revenue by Product Type, 2008...................................................................................................................................................237Fig.28: Percentage of bioMérieux’ Revenue by Region, 2008 ............................................................................................................................................................238

Bio-Rad Laboratories ....................................................................................................................................................... 239Point-of-Care.HbA1c.Testing........................................................................................................................................................ 239TOX/See.Drugs-of-Abuse.Testing................................................................................................................................................ 239Current.Alliances............................................................................................................................................................................ 240

Chembio Diagnostics and Inverness Medical Innovations .....................................................................................................................................................240Calypte Biomedical ..................................................................................................................................................................................................................240

Calypte Biomedical ...........................................................................................................................................................241Aware.Rapid.Test.Product.Line.....................................................................................................................................................241

Aware HIV-1/2 OMT (Oral fluid) PRO (Professional) ................................................................................................................................................................ 242Aware HIV-1/2 Oral OTC ...........................................................................................................................................................................................................242Aware HIV-1/2 BSP PRO ...........................................................................................................................................................................................................242

Products.in.Development..............................................................................................................................................................242HIV-1/2 OMT Test Using a Synthetic Antigen ..........................................................................................................................................................................242Aware II (The Ani Platform) .....................................................................................................................................................................................................242

Current.Alliances.............................................................................................................................................................................243Manufacturing Contracts ........................................................................................................................................................................................................243

Financial.Performance...................................................................................................................................................................243Calypte Biomedical - Operating Results, 2004-2008 (US$ thousands) .............................................................................................................................................244Fig.29: Percentage of Calypte’s Revenue by Product, 2008 ................................................................................................................................................................245

Latest Results ...........................................................................................................................................................................................................................245Chembio Diagnostics ....................................................................................................................................................... 246

Recent Key Events ...............................................................................................................................................................................................................................246Rapid.HIV.Tests............................................................................................................................................................................... 246Other.Tests........................................................................................................................................................................................247In.Development.-.DPP.Platform...................................................................................................................................................247

DPP HIV 1/2 Screening Assay ...................................................................................................................................................................................................248DPP Syphilis Screen & Confirm ................................................................................................................................................................................................248DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests .....................................................................................................................................248DPP Influenza ..........................................................................................................................................................................................................................248DPP Leptospirosis ....................................................................................................................................................................................................................249

Current.Alliances.............................................................................................................................................................................249Inverness Medical Innovations ................................................................................................................................................................................................249US CDC ......................................................................................................................................................................................................................................250Infectious Disease Research Institute .....................................................................................................................................................................................250Foundation for Innovative and Novel Diagnostics..................................................................................................................................................................250Bio-Rad Laboratories ...............................................................................................................................................................................................................250Oswaldo Cruz Foundation .......................................................................................................................................................................................................251

Financial Performance ..................................................................................................................................................... 251Chembio - Operating Results, 2004-2008 (US$ thousands) ..............................................................................................................................................................252Chembio - Revenue by Type, 2006-2008 (US$ thousand) .................................................................................................................................................................252Chembio - Product Sales by Region, 2006-2008 (US$ thousand) .....................................................................................................................................................252Fig.30: Percentage of Chembio’s Revenue by Type, 2008...................................................................................................................................................................253Fig.31: Percentage of Chembio’s Product Sales by Region, 2008 .......................................................................................................................................................253

Latest Results ...........................................................................................................................................................................................................................253Concateno ........................................................................................................................................................................ 254

Recent Key Events ...............................................................................................................................................................................................................................254Cozart.Products.............................................................................................................................................................................. 254Euromed.Products......................................................................................................................................................................... 255

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Current.Alliances.and.Contracts.................................................................................................................................................. 255Philips .......................................................................................................................................................................................................................................255Ireland’s Defence Forces ..........................................................................................................................................................................................................255UK Home Office .......................................................................................................................................................................................................................255

Financial.Performance.................................................................................................................................................................. 256Concateno - Operating Results, 2007-2008 (£ million) ......................................................................................................................................................................256Concateno Revenue by Division, 2007-2008 (£ million) ....................................................................................................................................................................256Fig.32: Percentage of Concateno’s Revenue by Segment, 2008 .........................................................................................................................................................257Concateno Revenue by Industry, 2007-2008 (£ million) ....................................................................................................................................................................257Fig.33: Percentage of Concateno’s Revenue by Industry, 2008 ..........................................................................................................................................................258Concateno Revenue by Region, 2007-2008 (£ million) ......................................................................................................................................................................258Fig.34: Percentage of Concateno’s Revenue by Region, 2008 ............................................................................................................................................................258

DxCon ................................................................................................................................................................................ 259POC.Cardiovascular.Tests...............................................................................................................................................................259

Vyent ........................................................................................................................................................................................................................................259Cardiac STATus and Decision Point ..........................................................................................................................................................................................260

In.Development.-.Infectious.Disease.Tests................................................................................................................................ 260Current.Alliances.............................................................................................................................................................................261

HX Diagnostics .........................................................................................................................................................................................................................261Princeton BioMeditech ...........................................................................................................................................................................................................261

Genzyme Diagnostics ...................................................................................................................................................... 262Point.of.Care.Tests.......................................................................................................................................................................... 262

OSOM Influenza A & B Test ......................................................................................................................................................................................................262OSOM Ultra Strep A ..................................................................................................................................................................................................................262OSOM Strep A ...........................................................................................................................................................................................................................262OSOM Mono .............................................................................................................................................................................................................................263OSOM Trichomonas Rapid Test ................................................................................................................................................................................................263OSOM BVBLUE Test...................................................................................................................................................................................................................263OSOM ImmunoDip Urinary Albumin Test ...............................................................................................................................................................................263OSOM Pregnancy Tests ............................................................................................................................................................................................................263

Home Diagnostics Inc. ..................................................................................................................................................... 264TRUEtest.Test.Strips....................................................................................................................................................................... 264TRUE2go.and.TRUEresult.............................................................................................................................................................. 264TRUEread......................................................................................................................................................................................... 265TRUEmanager.Diabetes.Management.Software..................................................................................................................... 265Litigation.Settlement.-.Roche.Diagnostics................................................................................................................................ 265Financial.Performance.................................................................................................................................................................. 266Home Diagnostics - Operating Results, 2004-2008 (US$ million).....................................................................................................................................................267Home Diagnostics - Revenue by Source, 2006-2008 (US$ million) ...................................................................................................................................................267Fig.35: Percentage of Home Diagnostics’ Revenue by Source, 2008 ..................................................................................................................................................267

Latest Results and Outlook ......................................................................................................................................................................................................268Horiba ABX ........................................................................................................................................................................ 269

Haematology.Analysers................................................................................................................................................................ 269ABX Micros ES60.......................................................................................................................................................................................................................269ABX Micros 60...........................................................................................................................................................................................................................269ABX Micros CRP 200 .................................................................................................................................................................................................................269ABX Pentra 60C+ .....................................................................................................................................................................................................................270

ABX.Pentra.400.Clinical.Chemistry.Analyser..............................................................................................................................270Current.Alliances.............................................................................................................................................................................270

Tosoh and Trinity Biotech ........................................................................................................................................................................................................270Helena Laboratories .................................................................................................................................................................................................................270

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Financial.Performance...................................................................................................................................................................270Horiba Medical - Operating Results, 2006-2008 (¥ million) .............................................................................................................................................................271Fig.36: Percentage of Horiba ABX’ Revenue by Region, 2008* ..........................................................................................................................................................271

Instrumentation Laboratory ........................................................................................................................................... 272POC.Critical.Care.Diagnostics........................................................................................................................................................272

Synthesis Blood Gas Analysers ................................................................................................................................................................................................273Purchasing.Contracts.....................................................................................................................................................................273

MedAssets Supply Chain Systems ...........................................................................................................................................................................................273Premier .....................................................................................................................................................................................................................................273HealthTrust Purchasing Group .................................................................................................................................................................................................273

International Technidyne Corporation ...........................................................................................................................274Hemochron.Whole.Blood.Coagulation.System.........................................................................................................................274

Hemochron Signature Elite and Hemochron Signature Plus Microcoagulation .................................................................................................................. 274Hemochron Response ..............................................................................................................................................................................................................275

IRMA.TRUpoint.Blood.Analysis.System.......................................................................................................................................275AVOXimeter.Whole.Blood.CO.Oximeter.and.Oximeter...........................................................................................................275ProTime.Microcoagulation.System..............................................................................................................................................275Hgb.Pro.Professional.Hemoglobin.Testing.System..................................................................................................................276Current.Alliances.............................................................................................................................................................................276

Medical Automation Systems .................................................................................................................................................................................................276Financial.Performance...................................................................................................................................................................276International Technidyne Operating Results, 2004-2008 (US$ million) ...........................................................................................................................................277Fig.37: International Technidyne Revenue, 2000-2008 (US$ million) ...............................................................................................................................................277

Inverness Medical Innovations ....................................................................................................................................... 278Recent Key Events ...............................................................................................................................................................................................................................280POC.Professional.Diagnostic.Products....................................................................................................................................... 280

Cardiology ................................................................................................................................................................................................................................280Women’s Health .......................................................................................................................................................................................................................281Infectious Diseases ...................................................................................................................................................................................................................281Oncology ..................................................................................................................................................................................................................................282Drugs of Abuse .........................................................................................................................................................................................................................282

Consumer.Products....................................................................................................................................................................... 283First Check Consumer Diagnostics Products ...........................................................................................................................................................................283

Mergers.&.Acquisitions................................................................................................................................................................. 283Genecare, Zycare, Medim and Biosyn .....................................................................................................................................................................................283Concateno ................................................................................................................................................................................................................................283ACON Laboratories’ Rapid Diagnostics Assets ........................................................................................................................................................................283Vision Biotech and Global Diagnostics CC ...............................................................................................................................................................................284Matria Healthcare ....................................................................................................................................................................................................................284BBI Holdings ............................................................................................................................................................................................................................284Panbio ......................................................................................................................................................................................................................................284Earlier Acquisitions ...................................................................................................................................................................................................................285

Joint.Ventures................................................................................................................................................................................. 286SPD Swiss Precision Diagnostics ..............................................................................................................................................................................................286

Current.Alliances............................................................................................................................................................................ 287Mediwatch ...............................................................................................................................................................................................................................287PrognostiX ...............................................................................................................................................................................................................................287Akers Biosciences ....................................................................................................................................................................................................................287Thermo Fisher Scientific ..........................................................................................................................................................................................................287Chembio ...................................................................................................................................................................................................................................288Trinity Biotech ..........................................................................................................................................................................................................................288

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Siemens ....................................................................................................................................................................................................................................288Litigation.......................................................................................................................................................................................... 288

FTC Settlement .........................................................................................................................................................................................................................288OraSure Technologies ..............................................................................................................................................................................................................289Beckman Coulter ......................................................................................................................................................................................................................289

Financial.Performance.................................................................................................................................................................. 289Inverness - Operating Results, 2004-2008 (US$ million) ...................................................................................................................................................................290Fig.38: Percentage of Inverness’ Revenue by Segment, 2008 ............................................................................................................................................................291Fig.39: Percentage of Inverness’ Revenue by Region, 2008 ...............................................................................................................................................................291Inverness Professional Diagnostics Operating Results, 2004-2008 (US$ million) .............................................................................................................................291Inverness Consumer Diagnostics Operating Results, 2004-2008 (US$ million) ................................................................................................................................292

Latest Results ...........................................................................................................................................................................................................................292Outlook and Strategy ...............................................................................................................................................................................................................292

LifeScan ............................................................................................................................................................................. 294Recent Key Events ...............................................................................................................................................................................................................................294Blood.Glucose.Monitoring.Products.......................................................................................................................................... 294

Consumer Products ..................................................................................................................................................................................................................295Hospital Products .....................................................................................................................................................................................................................297Test Strips .................................................................................................................................................................................................................................298

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

ResMed .....................................................................................................................................................................................................................................299t+ Medical ................................................................................................................................................................................................................................299Medtronic .................................................................................................................................................................................................................................300Debiotech .................................................................................................................................................................................................................................300Medical Automation Systems .................................................................................................................................................................................................300Telcor ........................................................................................................................................................................................................................................300Novo Nordisk ............................................................................................................................................................................................................................301

Financial.Performance...................................................................................................................................................................301J&J Diabetes Care Revenue, 2004-2008 (US$ million).......................................................................................................................................................................301Fig.40: LifeScan Sales by Region, 2008 ..............................................................................................................................................................................................301Fig.41: LifeScan Sales, 2004-2008 (US$ million) ................................................................................................................................................................................302

MedMira ........................................................................................................................................................................... 303Recent Key Events ...............................................................................................................................................................................................................................304Rapid.Tests....................................................................................................................................................................................... 304

Multiplo HIV/HCV .....................................................................................................................................................................................................................305Multiplo HBV/HIV/HCV.............................................................................................................................................................................................................305HIV Tests ...................................................................................................................................................................................................................................305Hepatitis Tests ..........................................................................................................................................................................................................................305MiraWellhp Test H. pylori Test .................................................................................................................................................................................................306

R&D.Activities................................................................................................................................................................................. 306New Combination Tests ...........................................................................................................................................................................................................306

Current.Alliances............................................................................................................................................................................ 307Triplex International Biosciences .............................................................................................................................................................................................307VWR International ...................................................................................................................................................................................................................307US CDC ......................................................................................................................................................................................................................................307Tri-Star Industries .....................................................................................................................................................................................................................307Vitest ........................................................................................................................................................................................................................................307Shenzhen Kang Sheng Bao Bio-Technology ...........................................................................................................................................................................307Pan American Health Organization .........................................................................................................................................................................................308

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HealthCare Asia MediTech .......................................................................................................................................................................................................308INyDIA Diagnóstico ..................................................................................................................................................................................................................308Voden Medical Instruments ...................................................................................................................................................................................................308IKXUR ........................................................................................................................................................................................................................................308

Financial.Performance.................................................................................................................................................................. 308MedMira - Operating Results, 2004-2008 (C$ thousands)................................................................................................................................................................309MedMira - Revenue by Region, 2007-2008 (C$ thousands) ..............................................................................................................................................................309Fig.42: MedMira - Revenue by Region, 2008 .....................................................................................................................................................................................310

Latest Results ........................................................................................................................................................................................................................... 310Medtronic ...........................................................................................................................................................................311

CGM.Systems....................................................................................................................................................................................311Recent Key Events ............................................................................................................................................................................................................................... 312

Paradigm Veo System .............................................................................................................................................................................................................. 312CGMS iPro Recorder.................................................................................................................................................................................................................. 312Guardian REAL-Time System ................................................................................................................................................................................................... 313Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System ............................................................................................................... 313OneTouch UltraLink Meter ....................................................................................................................................................................................................... 313Clinical Trials ............................................................................................................................................................................................................................. 314Research and Development .................................................................................................................................................................................................... 315Litigation - Nova Biomedical ................................................................................................................................................................................................... 315Alliances - LifeScan and Roche ............................................................................................................................................................................................... 315

Cardiac.Surgery.POC.Products.....................................................................................................................................................316ACT Plus Automated Coagulation Timer System .................................................................................................................................................................... 316HMS PLUS Haemostasis Management System ....................................................................................................................................................................... 316

Financial.Performance...................................................................................................................................................................316Fig.43: Medtronic Diabetes Revenue, 2005-2009 (US$ million) ........................................................................................................................................................ 317Fig.44: Medtronic Diabetes Revenue by Region, 2009 ....................................................................................................................................................................... 317

Latest Results and Outlook ...................................................................................................................................................................................................... 317Meridian Bioscience ..........................................................................................................................................................318

Recent Key Events ...............................................................................................................................................................................................................................318TRU.FLU.and.TRU.RSV.....................................................................................................................................................................318C.difficile.Tests.................................................................................................................................................................................318ImmunoCard.STAT!.HPSA.H..pylori.Test......................................................................................................................................319ImmunoCard.STAT!.Rotavirus.......................................................................................................................................................319ImmunoCard.STAT!.Strep.A...........................................................................................................................................................319Current.Alliances.............................................................................................................................................................................319

Premier ..................................................................................................................................................................................................................................... 319Immuno Pty Ltd and Scott Pharma ........................................................................................................................................................................................ 319Somagen Diagnostics .............................................................................................................................................................................................................. 319

Financial.Performance...................................................................................................................................................................320Meridian Bioscience - Operating Results, 2004-2008 (US$ million) ..................................................................................................................................................321Meridian Bioscience - Third-Party Sales by Segment, 2004-2008 (US$ million)...............................................................................................................................321Meridian Bioscience - Operating Income by Segment, 2006-2008 (US$ million) .............................................................................................................................321Fig.45: Meridian - Revenue by Segment, 2008 ..................................................................................................................................................................................322Meridian Bioscience - International Revenue by Source, 2005-2008 (US$ million) ..........................................................................................................................322

Fiscal 2009 and 2010 Outlook..................................................................................................................................................................................................322Nova Biomedical ............................................................................................................................................................... 323

Recent Key Events ...............................................................................................................................................................................................................................323StatStrip.Hospital.Blood.Glucose.Analysers...............................................................................................................................323Self-Testing.Blood.Glucose.Analysers.........................................................................................................................................324

Nova Max .................................................................................................................................................................................................................................. 324

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Nova Max Link .......................................................................................................................................................................................................................... 324Nova Max Test Strips ................................................................................................................................................................................................................ 324

Statsensor.Creatinine.Meter.........................................................................................................................................................324Whole.Blood.Stat.Testing..............................................................................................................................................................324

Stat Profile Critical Care Xpress ............................................................................................................................................................................................... 324Stat Profile pHOx .....................................................................................................................................................................................................................325

Nova.Electrolyte/Chemistry.Analysers.......................................................................................................................................325Patient.Data.Manager.(PDM)........................................................................................................................................................326Current.Alliances.............................................................................................................................................................................326

ACIST Medical Systems ............................................................................................................................................................................................................326Litigation...........................................................................................................................................................................................326

Medtronic .................................................................................................................................................................................................................................326Abbott ......................................................................................................................................................................................................................................327

OraSure Technologies ...................................................................................................................................................... 328Recent Key Events ...............................................................................................................................................................................................................................328OraQuick.Rapid.Test.Platform......................................................................................................................................................328

OraQuick ADVANCE HIV-1/2 ....................................................................................................................................................................................................329Q.E.D..Saliva.Alcohol.Test...............................................................................................................................................................329Products.in.Development..............................................................................................................................................................329

OraQuick HCV Test ...................................................................................................................................................................................................................329OraQuick HIV OTC Test .............................................................................................................................................................................................................330

Current.Alliances.............................................................................................................................................................................330Premier .....................................................................................................................................................................................................................................330Schering-Plough ......................................................................................................................................................................................................................330Ortho-Clinical Diagnostics .......................................................................................................................................................................................................331

Litigation...........................................................................................................................................................................................331Inverness Medical Innovations and Church & Dwight............................................................................................................................................................331

Financial.Performance...................................................................................................................................................................331OraSure - Operating Results, 2004-2008 (US$ million) .....................................................................................................................................................................332OraSure - OraQuick Sales by Customer Type, 2004-2008 (US$ thousands) .......................................................................................................................................333Fig.46: OraSure - Revenue by Product Line, 2008 ..............................................................................................................................................................................333Fig.47: OraQuick Revenue by Customer Type, 2008 ...........................................................................................................................................................................333

Latest Results and Outlook ......................................................................................................................................................................................................334Orion Diagnostica ............................................................................................................................................................. 335

QuikRead.System............................................................................................................................................................................335Uricult.Dipslide.Tests......................................................................................................................................................................335Rotaviral.and.Adenoviral.Enteritis.Tests.....................................................................................................................................336Financial.Performance...................................................................................................................................................................336Orion Diagnostica - Operating Results, 2004-2008 (EUR million) .....................................................................................................................................................337

OrSense ............................................................................................................................................................................. 338NBM-200MP.Multi-Parameter.Sensor.........................................................................................................................................338

Clinical Trial Results .................................................................................................................................................................................................................338NBM-200G........................................................................................................................................................................................339

Phamatech ........................................................................................................................................................................ 340Drugs.of.Abuse.Tests..................................................................................................................................................................... 340

At Home Drug Test ...................................................................................................................................................................................................................340QuickScreen..............................................................................................................................................................................................................................340QuickScreen Plus ......................................................................................................................................................................................................................340QuickScreen Cup ......................................................................................................................................................................................................................340QuickScreen Dipsticks and Cassettes ......................................................................................................................................................................................341

Pregnancy.and.Fertility.Testing...................................................................................................................................................341

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Quest Diagnostics ............................................................................................................................................................. 342Recent Key Events ...............................................................................................................................................................................................................................342HemoCue.Products........................................................................................................................................................................ 342

Haemoglobin Systems .............................................................................................................................................................................................................343Blood Glucose Testing ..............................................................................................................................................................................................................343HemoCue Albumin 201 System ...............................................................................................................................................................................................344HemoCue White Blood Cell Analyzer ......................................................................................................................................................................................344

Enterix.Products............................................................................................................................................................................. 345InSure Quik F I T Fecal Immunochemical Test .........................................................................................................................................................................345

Focus.Diagnostics’.POC.Products................................................................................................................................................ 346HerpeSelect Express HSV-2......................................................................................................................................................................................................346Focus Dengue Rapid Tests .......................................................................................................................................................................................................346

Current.Alliances.............................................................................................................................................................................347Medical Automation Systems .................................................................................................................................................................................................347MEC Dynamics .........................................................................................................................................................................................................................347

Financial.Performance...................................................................................................................................................................347Quest Diagnostics - Operating Results, 2004-2008 (US$ million) .....................................................................................................................................................348Quest Diagnostics - Sales and Earnings by Category, 2004-2008 (US$ million) ...............................................................................................................................348Fig.48: Quest Diagnostics - Revenue by Division, 2008 ......................................................................................................................................................................349Fig.49: Quest Diagnostics - Revenue by Product Type, 2008..............................................................................................................................................................349

Latest Results and Outlook ......................................................................................................................................................................................................349Quidel .................................................................................................................................................................................351

Infectious.Disease.Tests.................................................................................................................................................................351QuickVue Influenza Tests .........................................................................................................................................................................................................351QuickVue Group A Strep Tests..................................................................................................................................................................................................351QuickVue RSV Test ....................................................................................................................................................................................................................351

Reproductive.and.Women’s.Health.............................................................................................................................................352QuickVue.iFOB.................................................................................................................................................................................352QuickVue.H..Pylori.gII.Test.............................................................................................................................................................352Current.Alliances.............................................................................................................................................................................352

bioMerieux ...............................................................................................................................................................................................................................352Financial.Performance...................................................................................................................................................................353Quidel - Operating Results, 2004-2008 (US$ million) .......................................................................................................................................................................353Quidel - Revenue by Product Type, 2005-2008 (US$ million) ............................................................................................................................................................354Quidel - Revenue by Region, 2005-2008 (US$ million)......................................................................................................................................................................354Fig.50: Quidel - Revenue by Product Type, 2008 ................................................................................................................................................................................354Fig.51: Quidel - Revenue by Region, 2008 ..........................................................................................................................................................................................355

Latest Results ...........................................................................................................................................................................................................................355Radiometer ....................................................................................................................................................................... 356

Recent Key Events ...............................................................................................................................................................................................................................356Blood.Gas.Analysers...................................................................................................................................................................... 356

1st automatic ...........................................................................................................................................................................................................................356ABL80 FLEX ...............................................................................................................................................................................................................................357ABL800 FLEX ............................................................................................................................................................................................................................357ABL77 .......................................................................................................................................................................................................................................357ABL5 .........................................................................................................................................................................................................................................358NPT7 .........................................................................................................................................................................................................................................358

RADIANCE.IT.system...................................................................................................................................................................... 358Quality.Control............................................................................................................................................................................... 358AQT90.FLEX.Immunoassay.Analyser.......................................................................................................................................... 358Current.Alliances.............................................................................................................................................................................359

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Roche ........................................................................................................................................................................................................................................359Medical Automation Systems .................................................................................................................................................................................................359Veterans Integrated Services Network ...................................................................................................................................................................................359

Financial.Performance.................................................................................................................................................................. 360Fig.52: Radiometer - Revenue by Region, 2008 .................................................................................................................................................................................360

Response Biomedical ........................................................................................................................................................361Recent Key Events ...............................................................................................................................................................................................................................361RAMP.System.................................................................................................................................................................................. 362

Respiratory Syncytial Virus Test ..............................................................................................................................................................................................3623M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay..............................................................................................................................................362RAMP NT-proBNP Test .............................................................................................................................................................................................................363Other Cardiac Markers .............................................................................................................................................................................................................363

Current.Alliances............................................................................................................................................................................ 363Foundation for Innovative New Diagnostics ..........................................................................................................................................................................363Roche ........................................................................................................................................................................................................................................3643M .............................................................................................................................................................................................................................................364Shionogi ...................................................................................................................................................................................................................................364

Financial.Performance.................................................................................................................................................................. 365Response Biomedical - Operating Results, 2004-2008 (C$ thousands) ............................................................................................................................................365Response Biomedical - Product Sales by Category, 2006-2008 (C$ thousands) ...............................................................................................................................366Fig.53: Response Biomedical - Product Sales by Category, 2008 .......................................................................................................................................................366Response Biomedical - Product Sales by Region, 2006-2008 (C$ thousands) ..................................................................................................................................366Fig.54: Response Biomedical - Product Sales by Region, 2008 ..........................................................................................................................................................367

Latest Results ...........................................................................................................................................................................................................................367Roche Diagnostics ............................................................................................................................................................ 368

Recent Key Events ...............................................................................................................................................................................................................................368Professional.Diagnostics............................................................................................................................................................... 369

CoaguChek Systems .................................................................................................................................................................................................................369Cardiac Testing Products .........................................................................................................................................................................................................369Hospital Blood Glucose Monitoring ........................................................................................................................................................................................371Urinalysis ..................................................................................................................................................................................................................................372

Diabetes.Care...................................................................................................................................................................................372Blood Glucose Meters ..............................................................................................................................................................................................................372Data Management Tools..........................................................................................................................................................................................................373

Current.Alliances.and.Contracts...................................................................................................................................................374Radiometer .............................................................................................................................................................................................................................. 374Response Biomedical ............................................................................................................................................................................................................... 374Home Diagnostics Inc. ............................................................................................................................................................................................................. 374Medical Automation Systems ................................................................................................................................................................................................. 374bioMérieux ...............................................................................................................................................................................................................................375Inverness Medical Innovations ................................................................................................................................................................................................375Dade Behring (Siemens) ..........................................................................................................................................................................................................375

Financial.Performance...................................................................................................................................................................375Roche Diagnostics Operating Results, 2004-2008 (SFr million) ........................................................................................................................................................377Roche Diagnostics Sales by Product Line, 2007-2008 (SFr million) ...................................................................................................................................................377Roche Diagnostics Sales by Region, 2007-2008 (SFr million) ............................................................................................................................................................377Fig.55: Roche Diagnostics - Revenue by Product Line, 2008 ..............................................................................................................................................................378Fig.56: Roche Diagnostics - Revenue by Region, 2008 .......................................................................................................................................................................378

Latest Results ...........................................................................................................................................................................................................................378Siemens Healthcare ......................................................................................................................................................... 380

Blood.Gas.Analyser.Range............................................................................................................................................................ 380

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RAPIDLab Analysers .................................................................................................................................................................................................................380RAPIDPoint 340/350 Blood Gas Systems ................................................................................................................................................................................381RAPIDPoint 400 Series .............................................................................................................................................................................................................381RapidComm .............................................................................................................................................................................................................................381

PFA-100.Platelet.Function.Analyser.............................................................................................................................................381Urinalysis.......................................................................................................................................................................................... 382

Clinitek Advantus Analyzer ......................................................................................................................................................................................................382Clinitek Status Analyser ...........................................................................................................................................................................................................382Multistix10 SG Reagent Strips .................................................................................................................................................................................................382Clinitek Microalbumin Strips ...................................................................................................................................................................................................382Clinitest hCG Pregnancy Test ...................................................................................................................................................................................................383

Diabetes.Testing.-.DCA.Vantage.Analyser................................................................................................................................. 383Cardiology....................................................................................................................................................................................... 383Current.Alliances............................................................................................................................................................................ 383

Beckman Coulter ......................................................................................................................................................................................................................383Roche ........................................................................................................................................................................................................................................384Sysmex .....................................................................................................................................................................................................................................384

Financial.Performance.................................................................................................................................................................. 384Thermo Fisher Scientific .................................................................................................................................................. 385

Sure-Vue.Tests................................................................................................................................................................................ 385Remel’s.Xpect.Tests........................................................................................................................................................................ 386Alliances........................................................................................................................................................................................... 386

Inverness Medical Innovations ................................................................................................................................................................................................386Trinity Biotech ................................................................................................................................................................... 387

POC.HIV.Tests.................................................................................................................................................................................. 387Uni-Gold Recombigen HIV .......................................................................................................................................................................................................387Capillus HIV-1/HIV-2 .................................................................................................................................................................................................................388In Development - TRIstat POC System ....................................................................................................................................................................................388

Uni-Gold.Legionella.Urinary.Antigen.(LUA).............................................................................................................................. 388Current.Alliances............................................................................................................................................................................ 388

Akers Biosciences ....................................................................................................................................................................................................................388Horiba ABX ...............................................................................................................................................................................................................................388Clinton Foundation HIV/AIDS Initiative ...................................................................................................................................................................................388Community Healthcare Network ............................................................................................................................................................................................389Inverness Medical Innovations ................................................................................................................................................................................................389Planned Parenthood Federation of America ..........................................................................................................................................................................389

Financial.Performance.................................................................................................................................................................. 389Trinity Biotech Operating Results, 2004-2008 (US$ million) .............................................................................................................................................................390Trinity Biotech - Sales by Product Line, 2004-2008 (US$ million) .....................................................................................................................................................390Fig.57: Trinity Biotech - Sales by Product Type, 2008 .........................................................................................................................................................................390Trinity Biotech - Sales by Geographic Region, 2004-2008 (US$ million) ...........................................................................................................................................391Fig.58: Trinity Biotech - Sales by Region Type, 2008 ..........................................................................................................................................................................391

Latest Results ...........................................................................................................................................................................................................................391APPENDICES .............................................................................................................................................. 392

APPENDIX.1.-.LIST.OF.ABBREVIATIONS..............................................................................................................................392APPENDIX.2.-.REPORT.METHODOLOGY.............................................................................................................................393

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Documents

POC Diagnostics- Future Players and Prospects