The Future of Clinical Chemistry and Laboratory …

1 The Future of Clinical Chemistry and Laboratory medicine , The diagnostics industry View Peng Yin, , , Director, Global Scientific Affairs Abbott Diagnostic Division (ADD). Agenda Lack of perceived value of Laboratory medicine Informactics: A solution for addressing Laboratory and health system challenges Immunoassay diagnostics is still a main and fast growing segment in diagnostics Molecular diagnostics : companion diagnostics play a key part of personalized medicine Point-of-Care (POC). IVD market in emerging nations Central Role of Laboratory medicine 70%.

2 OF Clinical DECISIONS. ARE INFORMED BY DATA. FROM Laboratory . medicine . 4%. SPEND. As Is : Healthcare industry High 5. Relative Offering Level 4. 3. 2. 1. Low 0. Price/Cost Quality Clinical Career Public Government of Life Outcome Attractiveness Perception Perception Pharma Nursing Pathology Clinical Specialist Reimbursement Reduction Trend for IVD in Japan $ Billion . -2%. 400 -3% 0. -5%. 350 -3% -10. -7%. 300. -7% -20. 250. -30. 200. -14%. -40. 150 -11%. -50. 100. -11% -60. 50. 0 -70. 1990 1992 1994 1996 1998 2000 2002 2004 2006.

3 Medical Expense Reimbursement Level $ = \95. IVD Product Approval Period (Reviewer Time). TARGET APPROVAL TIME DEFINED BY REGULATOR: 180 DAYS. Reviewer Time in Days 800. Max: 706. 600. Ave: 549. Max: 543. 400. Min: 346. Ave: 313. 200. Min: 71. 0. With (5 cases) Without (58 cases). SPECIAL CONSULTATION. PMDA. Special Number Reviewer Time Within 6 months (184 days). Consultation of Cases Average Minimum Maximum Number of Achievement Cases rate With 5 549 346 706 0 0 . Without 58 313 71 543 15 . Source: IVD Approval Cycle Time Survey 2010, Analyzed by LEK.

4 Collaboration Opportunities for Laboratory Professional Associations and industry IMPROVE RECOGNITION OF VALUABLE. CONTRIBUTIONS OF IVD TO HEALTHCARE. ASSOCIATIONS AND industry WORK TOGETHER WITH. Laboratory PROFESSIONALS, CUSTOMERS AND. GOVERNMENT TO INFLUENCE HEALTH POLICIES AND. THE REIMBURSEMENT SYSTEM IN ORDER TO IMPROVE. HEALTHCARE AND PATIENT'S QOL. Helping to Secure the Future of the Lab Profession IFCC-Abbott Visiting Lecturer Programme 2012 Turning Science Into Caring (TSIC) Symposium on Oct 15-16, Shanghai, China PARTNERING WITH IFCC AND CSLM.

5 Symposium Theme: Healthcare in the 21st Century: Evolving Trends in Laboratory medicine To Be : Healthcare industry High 5. Relative Offering Level 4. 3. 2. 1. Low 0. Price/Cost Quality Clinical Career Public Government of Life Outcome Attractiveness Perception Perception Pharma Nursing Pathology Clinical Specialist Informatics HEALTHCARE: THE NEXT 10 YEARS OF CHANGE. Informatics is a solution for addressing Laboratory and health system challenges. Medical Informatics at the Hospital Clinical INFORMATION. SYSTEM ON PHYSICIAN'S.

6 WORKSTATION. PICTURE ARCHIVING. Physician & COMMUNICATION. Office Outpatient SYSTEM (PACS). RADIOLOGY Imaging INFORMATION Center SYSTEM. Radiology NURSING ADMINISTRATIVE &. INFORMATION. HIM FINANCIAL SYSTEM. PHARMACY SYSTEM. INFORMATION. SYSTEM ADT. SYSTEM. Administration Emergency Pharmacy Laboratory . INFORMATION. SYSTEM Registration Laboratory Informatics Aims to expedite the exchange of Laboratory data using data networks. The field involves developing systems and standards to facilitate and expedite the acquisition, retrieval and communication of test results and other Laboratory data.

7 Abbott's OneLab Informatics Solutions INVENTORY MANAGER. KEEP TRACK OF THE REAGENTS AND. SUPPLIES. A SINGLE PLATFORM AND Measure Actual Target Achievement LOGIN. Turnaround Time Collection 25. 12. 100%. 100% . DECISION CENTER. Errors Lab Reporting Errors Proficiency 10. 25. 100%. TAKES Laboratory DATA. Testing Analytic Systems Quality 25 100% AND GENERATES. Scorecards Dashboards Graphs STATISTICS AND REPORTS. SMART CENTER. INTERFACE MULTIPLE. Action Triggers INSTRUMENTS. Visual Alerts Stoplights 15. Immunoassay diagnostics : a main and fast growing segment in diagnostics IVD market grew by 6% from 2008 to 2009, putting the total worldwide market at $42 billion A 5% annual growth rate will put the total worldwide IVD market at $ billion by 2014.

8 Compared with a 3% growth rate for Clinical Chemistry and a 5%. growth rate for hematology, Immunoassay diagnostics is expect to grow at 9%, driven by technology advances such as ultrasensitive detection system, assays and novel biomarkers Ultrasensitive Detection System Project Q is a full-scale revisioning next generation of integrated Diagnostic systems and services covering Hematology, core IACC. testing and blood screening, plus informatics Concept Development, Review and Prototypes Ultrasensitive Detection Assays-hsTnI.

9 ARCHITECT TnI* ARCHITECT hsTnI**. g/L ng/L g/L ng/L. (ng/mL) (pg/mL) (ng/mL) (pg/mL). LoD 10 10%CV 32 99%ile 28 % Detectable above LoD <50% of normals >50% of normals *Representative data from package insert **Internal R&D Final Verification Data ~7x improvement in precision Better LoD, enable 2 hours rule out rather than 3 serial troponins over 8-12 hours- quicker and more accurate diagnosis of ACS, as it is able to read below the 99th percentile (rule in or out by 2 hr TnI delta). Molecular diagnostics : Personalized medicine and Companion diagnostics THE RIGHT medicine , AT THE RIGHT DOSE, TO THE RIGHT PATIENT, AT THE RIGHT TIME.

10 Personalized medicine involves co-development of drugs/devices and specialized diagnostic tests . also referred to as Companion diagnostics . Companion Diagnostic opportunities may be identified at any point in the IVD development life cycle DESIGN VALIDATION/VERIFICATION MARKET. DISCOVERY RESEARCH PHASE CONTROL REGULATORY APPROVALS LAUNCH. Collaborations leading to Products in development may Products on market may have biomarker identification be identified with Companion Companion Dx potential Dx potential (eg.)