View
226
Download
0
Category
Preview:
Citation preview
15 June 2010 page 1 © 2009 Roche
Future Directions in POC Testing – An Industry ViewTrilateral Workshop – French Embassy Berlin16 June 2010
Nicholas Smith – Roche Professional Diagnostics
15 June 2010 page 3 © 2009 Roche
Roche Diagnostics and Trends in the IVD-Market
The PoC Worldwide Market
PoC Testing – Trends and Future
Challenges for the Industry
15 June 2010 page 4 © 2009 Roche
Roche worldwideTwo Divisions… Common Focus Personalized Healthcare
Roche PharmaceuticalsRoche Diagnostics
RocheAppliedScience
RocheProfessionalDiagnostics
RocheMolecular
Diagnostics
Roche Tissue
Diagnostics
RocheDiabetes
Care
GenentechRochePharma
Chugai
15 June 2010 page 5 © 2009 Roche
Roche Diagnostics DivisionProducts for the Laboratory, Clinic and Patient
Research Professionals Consumers
Applied Science
research academia pharma biotech university hospital commercial lab hospital clinic GP patient
Molecular Diagnostics
Life science research Diagnostics market
Diabetes Care
Tissue Diagnostics
Professional Diagnostics
15 June 2010 page 6 © 2009 Roche
Roche Diagnostics – Strategic FocusInnovation and Efficiency
Medical Value• Innovative medicines• Evidence-based decisions• Trend to De/Centralization• Workflow / IT-Complexity• Lack of personnel• Cost reduction
Global Trends …
Testing Efficiency
15 June 2010 page 7 © 2009 Roche
Roche Professional DiagnosticsSystem Innovation … (= Marker/Test and Instrument)
Testing efficiency
Marker/Test
portfolio
Workflowand connectivity
System-
concept
15 June 2010 page 8 © 2009 Roche
Roche Professional DiagnosticsImproved Outcomes…
Test/Marker
innovation
Algorithms and
interpretation
Decentralization
of
testing
Medical value
page 9 © 2009 Roche
University Lab Reference-Lab Stat Lab ICU ER OR OP GP Patient
Needs:Maximum efficiency
High throughputWidest test-menu
Lowest cost
Roche Professional DiagnosticsThe Continuum of IVD from Lab to Patient…
Needs:Time critical
Clinical decision criticalLimited critical parametersComparability with the Lab
Needs:Chronic care
Simple handlingConsistent results
Low cost
page 10 © 2009 Roche
University Lab Reference-Lab Stat Lab ICU ER OR OP GP Patient
Roche Professional DiagnosticsThe Continuum of IVD from Lab to Patient…
Inflammatory and Autoimmune Diseases
Metabolic Diseases
Oncology
Renal Diseases
Thromophilia / haemophilia
Cardiovascular Disease
Diabetes
Hepatitis
HIV
Infectious Diseases
15 June 2010 page 11 © 2009 Roche
Clin.Chem.
GlucoseCardiac Markers
Bloodgas / Electrolytes
Lactate
Coagulation
Data Management
Roche Professional Diagnostics - PoCT
HematologyUrine analysis
15 June 2010 page 12 © 2009 Roche
Roche Professional Diagnostics - PoCTEnabling Decentralization Through IT
Decentralized testing Central control
15 June 2010 page 13 © 2009 Roche
•CBC
•PT•PTT•Fibrinogen•Coag Factors
Sensor
CellcountImmuno
Urine Strip
Chemistry
Coagulation
•Platelets
PlateletActivation
HCT ACT•Glucose•Electrolytes•Urea•CREA•tCO2•Lactate•ALB•ALP•AST•TBIL•TP•D-Dimer•CRP•HbA1c•Urin Albumin•LDL•HDL•Trig•Cholesterol•ALT•Phos•Cystatine
•Urine Profile•Urin Albumin
•Troponin•BNP•CK-MB•D-Dimer•CRP•PCT
•Glucose•Electrolytes•Urea•CREA•tCO2•Lactate•Blood Gas
PoCT – Multiple TechnologiesParameter overview …
15 June 2010 page 14 © 2009 Roche
Roche Diagnostics and Trends in the IVD-Market
The PoC Worldwide Market
PoC Testing – Trends and Future
Challenges for the Industry
15 June 2010 page 15 © 2009 Roche
PoCT – Right Information, Right Place, Right TimeFast – Accurate – Reproducible – Easy – Cost Competitive
Physician Office Lab
Operating Room
Emergency Room
Intensive Care Unit
Patient Self Testing
Testing Site Medical Need
Manage acute
conditions
Optimize patient
management
Fast and effective
triage
Reduce length of operation
Monitor chronic
conditions
Manage large patient numbers with broad spectrum of diseases and generate additional revenue (e.g. diabetes)
Keep freedom to self-manage disease or condition(e.g. atrial fibrillation)
Keep operations short to reduce occurrence of complications
Select patients who need immediate care from large number of patients (e.g. acute myocardial infarction)
Stabilize failing bodies with high mortality in a cost intensive setting (e.g. sepsis)
(Medical) Challenge
Hig
h C
ritic
ality
Tes
ting
(HC
T)
Hos
pita
l
Am
bula
tory
Car
e
(AC
T)
page 16 © 2009 Roche
High Criticality Testing
Fast and effective triage
Monitor criticalconditions
Ambulatory Care Testing
Efficient management of chronic diseases
High Criticality Testing
Fast and effective triage
Monitor critical conditions
Ambulatory Care Testing
Efficient management of chronic diseases
Bas
ic • General / initial diagnosis• Common patient monitoring parameters
5 parametersGlucose, CBC,
Electrolytes, Urea, Crea
4 subsegments9 parameters
Glucose, HbA1c, Cholesterol+, HDL+, LDL+, Triglyc+, ALT+, PT, Microalbumin
7 parametersGlucose, CBC,
Electrolytes, Urea, Crea, BG, Lactate
Leve
l 1
• Disease-specific requirements / subsegments
• Urgent diagnostic needs for treatment and/or workflow
8 subsegments17 parameters
Troponin, D-Dimers, BG, Lactate, CMP, PT, PTT, Fibrinogen, Urinalysis, ALT, GGT, AP, Lipase, Amylase, Coox, DAT,
MetHb
6 subsegments28 parameters
proBNP, CKMB, Electrolytes, BMP, Urea, Crea, Ca, Phos, Cystatin, PTT, Fibrinogen, Platelets, Coag.
factors, AP, GGT, Urinalysis, Anti-HCV, Anti-Hbs, TSH, Vit B12, Folat, Iron, Ferritin, Hb, HIV, FOBT, CMV, DAT
3 subsegments5 parameters
Troponin, CRP or PCT, PT, PTT, Fibrinogen
Leve
l 2 • Less urgent disease-specific requirements Covered by central / reference lab
8 subsegments24 parameters
proBNP, CKMB, CRP*, PCT, ALT*, GGT*, Bilirubin, PT,* PTT*,
Fibrinogen, Ca, Phos, ATIII, Lactate, Cystatin, Rapid Tests
(5), Liquor (4)< 40mins
< 20mins < 20mins Within total consultation time
< 20mins < 20mins Within total consultation time
PoCT – Right Information, Right Place, Right TimeWhat, Where and How Fast …
30 parameters needed to cover vast majority of diseases and cases
15 June 2010 page 17 © 2009 Roche
Roche Diagnostics and Trends in the IVD-Market
The PoC Worldwide Market
PoC Testing – Trends and Future
Challenges for the Industry
15 June 2010 page 18 © 2009 Roche
PoCT – Trends and Growth Areas…Decentralization and Medical Value….
• Diabetes Monitoring – Including Patient Self Testing; the largest PoCT segment
• Coagulation Therapy Monitoring – Future growth opportunities as countries grant reimbursement for Patient Self Testing, but new therapeutics may moderate growth
• Infectious Disease Diagnosis – e.g. MRSA, Sepsis
• Cardio-Vascular Diagnostics – Strong trend towards „lab-like“ performance at the point of care e.g. high sensitive Troponin
• Glucose and Blood Gas Monitoring – Key issues in Intensive Care Medicine• Possible automation of Glucose Monitoring
• Standard PoCT – Lipids, Liver, Kidney diagnostics and HbA1c are important screening parameters (Clinics, GP, Pharmacy)
15 June 2010 page 19 © 2009 Roche
Hospital PoCT – Applications… two examples
• Cardio-vascular Diagnostics
• Marker combinations
• Whole blood and plasma applications
• “Lab-like” performance at high-speed
• “Glycemic Control”
• Monitoring of blood glucose in critically ill patients
• Automated insulin-dosing algorithms
• ICU workflow improvement
15 June 2010 page 20 © 2009 Roche
PoCT Immunology System Concept Goal: Lab-Performance, Various Test Combinations
• Table-top System with Fluorescence detection
• Immuno-Parameter Tests from whole-blood
• Short TAT (< 15 min)
• Low blood volume (< 100 microL)
• RiLiBÄK and CLIA compliant
• Long reagent shelf-life
• Connectivity via POCT-1A Standard
15 June 2010 page 21 © 2009 Roche
Most important PoCT Criteria
PoCT Immunology System Concept Goal: Lab-Performance, Various Test Combinations
0 10 20 30 40 50 60 70
Performance
TAT
Convenience
Menu Breadth
Maintenance
Points (max: 70)
15 June 2010 page 22 © 2009 Roche
Troponin, NT-proBNP, SP-BCardiac vs non-cardiac or other causeAcute Dyspnoe
IL-6, CRP, PCT, Lipase, liver enzymes
Acute hepatitis, appendicitisAbdominal pain
S100, GF-APDifferentiation of hemorraghic and ischemic stroke in the early acute phase
Acute stroke
Troponin, NT-proBNP,D-Dimer, GDF-15
Rule-out of pulmonary embolism, myocardial infarction and right heartinvolvement
Chest Pain
ParameterDecisionSymptoms & Syndromes
Emergency Room (ER) /Intensive Care (ICU) – Test combinations for both locationsGoal: Risk Assessment
15 June 2010 page 23 © 2009 Roche
Hospital PoCT – Applications… two examples
HosPoCT - Cardio-vascular Diagnostics
• Marker combinations
• Whole blood and plasma applications
• “Lab-like” performance at high-speed
HosPoCT – “Glycemic Control”
• Monitoring of blood glucose in critically ill patients
• Automated insulin-dosing algorithms
• ICU workflow improvement
15 June 2010 page 25 © 2009 Roche
What is Glycemic Control?… Definition and Importance
Medical DefinitionCritically ill patients in stress situations exhibit elevation of their blood glucose concentrations (Stress Induced Hyperglycemia) which is associated with poorer outcomes. The Hyperglycemia is treated with intravenous insulin therapy
Why control blood glucose levels?Several published studies have shown outcome benefits from controlling patient’s blood glucose levels within certain ranges
Current practiceThe majority of ICU’s in developed countries practice some kind of glycemic control in the ICU despite ongoing scientific debate regarding appropriate ranges and avoidance of hypoglycemia. There is a strong need for new approaches to ease workflow (automation) and increase safety
15 June 2010 page 28 © 2009 Roche
Continuous Monitoring Microdialysis: In-situ measuring
Source: http://www.microdialysis.se/public/dokument.php?art=288&parent01=2&parent02=0&parent03=0&level2_4=true
Double-LumenMicrodialysis-Needle
15 June 2010 page 29 © 2009 Roche
Automated glucose testing Other approaches…
• Multiple companies developing solutions in this space
• Many different glucose measuring technologies with different pros and cons
• No consensus yet whether „true continuous“ measurement holds an advantage over „very frequent“ testing
• Optiscan has 510K approval, however no company has commercialized their solution and performance requirements are undefined
• Once performance is proven, potential high first mover advantage
Electrochemical sensor linked to
body interfaceRoche
Example technologies
Intravenous sensorDexCom/Edwards
NIR measurement of whole blood
Optiscan, Luminous Med.
Close to body sensor
15 June 2010 page 30 © 2009 Roche
Roche Diagnostics and Trends in the IVD-Market
The PoC Worldwide Market
PoC Testing – Trends and Future
Challenges for the Industry
15 June 2010 page 31 © 2009 Roche
PoCT – ChallengesGeneral Assumptions
• Higher Accuracy and Precision
• Improved Sensitivity & Specificity
• Lower Reagent and Blood volumes
• Shorter TAT = “turn-around-time”
• “Whole Blood Testing” = No pre-Analytic Steps
15 June 2010 page 32 © 2009 Roche
PoCT – ChallengesQuality
• “Lab-Like” Performance at the Point Of Care
• Quality Control
• System = Automatic/semi-automatic and on-board
• User = Training and Certification
• “Whole Blood” = Easy and Safe Handling
• Microfluidics = for the Lowest Sample Volume
• Multiplex-Assays = Multiple Tests from a single Sample
15 June 2010 page 33 © 2009 Roche
PoCT – ChallengesTechnology
• PoCT-specific; not “ex-Lab”
• Nanotechnologies (Fluidics, Reagent-Spotting, Washing = Lab-on- Chip)
• Focus on Therapy and Monitoring (= PHC)
• Development of Therapeutic and Monitoring-Tests
15 June 2010 page 34 © 2009 Roche
PoCT – ChallengesCost
• Reimbursement (Value of PoCT is recognized)
• “Price per Test” vs “turn-around-time”
• Mass Production in the Lab; Specificity at the Point of Care
• Increase the Number of Tests per System
• Patient Self Testing - Model
• Reimbursement
• Patient Training
• CLIA (USA) and RiLiBäk (D) – Stricter requirements
15 June 2010 page 35 © 2009 Roche
PoCT – ChallengesSummaryKey trends
• Hospital Point of Care Testing must be comparable to Lab results
• Growth of Point of Care in GP surgeries for screening, preventative diagnostics and therapy monitoring
• Patient self-testing for monitoring chronic diseases
For the industry…
• Technology – faster and more accurate results
• Greater combinations of tests (e.g. Cardio, Sepsis, Trauma, STAT)
• Higher quality standards (QC, lab-reference, shelf-life)
• Regulation compliant
• Lower costs for the user
15 June 2010 page 36 © 2009 Roche
Thank You For Your Attention!
Roche Diagnostics Ltd.6343 RotkreuzSwitzerland
COBAS, ACCUCHEK, COAGU-CHEK, REFLOTRON and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
This presentation is our intellectual property. Without our written consent, it shall neither be copied in any manner, nor used for manufacturing, nor communicated to third parties.
Recommended