nicholas smith – roche professional diagnostics … filetrilateral workshop – french embassy...

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


Roche Professional Diagnostics, Rotkreuz ??


Roche Diagnostics and Trends in the IVD-Market

The PoC Worldwide Market

PoC Testing – Trends and Future

Challenges for the Industry


Roche worldwideTwo Divisions… Common Focus Personalized Healthcare

Roche PharmaceuticalsRoche Diagnostics

RocheAppliedScience

RocheProfessionalDiagnostics

RocheMolecular

Diagnostics

Roche Tissue

Diagnostics

RocheDiabetes

Care

GenentechRochePharma

Chugai


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


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


Roche Professional DiagnosticsSystem Innovation … (= Marker/Test and Instrument)

Testing efficiency

Marker/Test

portfolio

Workflowand connectivity

System-

concept


Roche Professional DiagnosticsImproved Outcomes…

Test/Marker

innovation

Algorithms and

interpretation

Decentralization

of

testing

Medical value

© 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

© 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 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)

© 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


Troponin, D-Dimers, BG, Lactate, CMP, PT, PTT, Fibrinogen, Urinalysis, ALT, GGT, AP, Lipase, Amylase, Coox, DAT,

MetHb


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


Troponin, CRP or PCT, PT, PTT, Fibrinogen

Leve

l 2 • Less urgent disease-specific requirements Covered by central / reference lab


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 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 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.

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