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Enabling Point of Care Diagnostics 

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7:30 am Problem Solving Breakout Discussions with Continental Breakfast

TABLE: POC Diagnostics’ Role in Infectious Disease Prevention, Control, and Treatment

Moderator: Michel G.Bergeron, O.Q., M.D., FRCPC, Director and Founder, Centre de Recherche en Infectiologie de l’Université Laval

• From slow microbiology to rapid nucleic acid-based diagnostics
• Consequences of lack of rapid POC testing
• Applications and anticipated clinical impact of POC diagnostics
• Socio-economic benefits of POC testing
• POC testing and personalized healthcare

TABLE: The Role of the Pharmacist in Point-of-Care Testing

Moderator: Michael E. Klepser, Pharm.D., FCCP, Professor of Pharmacy, Ferris State University

• What type of tests should a pharmacist perform in a community setting?
• Do pharmacists training to interpret tests results and make treatment decisions?
• Is there a role for this type of practice in the patient centered medical home model?
• Is this practice cost-effective?

TABLE: The Feasibility of POC Diagnostics in Developing Countries

Moderator: Randy Allen, Ph.D., Manager, Corporate Relations, Clinton Health Access Initiative (CHAI)

• Setting standards that accelerate access to POC testing
• Projecting impact and cost-effectiveness of POC devices
• Ensuring strategic deployment of POC technology
• Assuring the quality of testing

TABLE: Point-of-Care or Central Lab Testing?

Moderator: Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Department of Laboratory Medicine, Lahey Clinic Medical Center

• Short introduction of the topic (5 minutes): Point-of-Care vs. Central Lab Testing, pros and cons

• State your interest and personal experience with POCT, and background (diagnostic lab, industry, regulatory, investment community, etc.).
• Do you have a POCT program?  If yes, which tests are performed in the POCT setting and why?
• Compare central lab and POCT options for the stated tests (quality, turn-around-time, cost and cost-effectiveness, regulation, patient and doctor satisfaction).
• Discuss the current user, technological, and market trends, and what the future might hold (disruptive new technologies, telemetry and self testing).

Sources of Error in POC Devices 

8:30 PANEL DISCUSSION: Sources of Error in POC Devices: Where Do Things Go Wrong in the Real World?

Moderator: James H. Nichols, Ph.D., DABCC, FACB, Professor of Pathology, Tufts University School of Medicine; Medical Director, Clinical Chemistry, Baystate Health

Panelists: Sheldon Campbell, M.D., Ph.D., F.C.A.P., Department of Laboratory Medicine, Yale University School of Medicine; Pathology and Laboratory Medicine, VA Connecticut

Christine C. Ginocchio, Ph.D., M. T. (ASCP), Chief, Division of Infectious Disease Diagnostics, Department of Pathology and Laboratory Medicine, Professor, Hofstra University North Shore-LIJ School of Medicine


This panel will discuss common problems in implementing point-of-care testing and identify potential solutions.  Issues to be discussed include:
• Operator error
• Environmental exposure
• Design flaws and limitations
• QC/calibration  issues
• Moving targets
• Application to new populations
• 510K renewal for multiplex assays and new primers

9:30 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


Health Economics 

10:25 Chairperson’s Remarks

Shuqi Chen, Ph.D., CEO, IQuum, Inc.

10:30 Health Economics of Point-of-Care Diagnostics – What is the Price of POC Tests?

Ala-SzczepuraAla Szczepura, D.Phil., Professor of Health Services Research, Division of Health Sciences, Warwick Medical School

This talk will consider economic issues associated with new point-of-care tests. It will use POC tests for infection detection as an example e.g. sepsis, tuberculosis, sexually transmitted infections and antimicrobial resistance. These four clinical/disease areas have recently been prioritised by the UK Department of Health and they form a major investment in innovation commissioned by the Technology Strategy Board.


11:00 Clinical Utility of New Point-of-Care Technologies and their Financial Impact to Hospitals

Gyorgy-AbelGyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Department of Laboratory Medicine, Lahey Clinic Medical Center

POCT is generally more expensive and more difficult to manage than tests on high-throughput central lab platforms. POCT can offer shorter turnaround times and convenience, and might impact outcomes. Implementing POCT programs requires careful analysis, including comparison of the quality of the results, potential errors in sample handling and reporting of the results, the additional physician, nurse, and medical technologist time, information technology, maintenance, quality control, regulatory requirements, and costs. The talk reviews the economy of POCT in the context of recent technological advancements and the changing healthcare environment, and offers real life examples of clinical chemistry and molecular diagnostics applications.

11:30 Transition to Plenary Session


Regulation of LDTs and RUOs

Alberto Gutierrez, Ph.D., Deputy Director, Office of in vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration

Moderated by: Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology & Medicine; Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine; President and CEO, Mayo Medical Laboratories and Mayo Collaborative Services, Inc.

12:45 pm Enjoy Lunch on Your Own


1:45 Views of the Laboratory Industry on Regulatory Issues

Alan Mertz, President, American Clinical Laboratory Association (ACLA)

2:10 Views of Diagnostics Manufacturers on Regulatory Issues

Andrew C. Fish, Executive Director, AdvaMedDx

2:30 Close of Enabling Point-of-Care Diagnostics

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