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Scientific Advisory Board
Sheldon Campbell, M.D., Ph.D., FCAP, Department of Laboratory Medicine, Yale University School of Medicine; Pathology and Laboratory Medicine, VA Connecticut
Shuqi Chen, Ph.D., CEO, IQuum, Inc.
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
Harry Glorikian, Founder & Managing Partner, Scientia Advisors LLC
Matthew Lorence, Ph.D., M.B.A., Senior Vice President, Marketing, Sales & Business Development, TessArae, LLC
James H. Nichols, Ph.D., DABCC, FACB, Professor of Pathology, Tufts University School of Medicine; Medical Director, Clinical Chemistry, Baystate Health
Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious Agents, Technology Strategy Board
Recommended Pre-Conference Short Courses*
*Separate registration required
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TUESDAY, AUGUST 21
7:30 am Registration and Morning Coffee
» KEYNOTE SESSION: MAKING THE CASE FOR POINT-OF-CARE TESTING
8:30 Chairperson’s Opening Remarks
Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious Agents, Technology Strategy Board
8:40 Revolutionary Point-of-Care (POC) Diagnostic Technologies to Improve the Prevention, Control and Treatment of Infectious Diseases
Michel G.Bergeron, O.Q., M.D., FRCPC, Director and Founder, Centre de Recherche en Infectiologie de l’Université Laval
In 2012, it still takes ≥2 days to identify most microbes responsible for infectious diseases. This lack of rapid diagnostics has led to empirical therapy, the overuse of antibiotics, and a dangerous increase in antibiotic resistance, hospital-acquired infections (HAI), and in deaths. Combining genomics, microfluidics, miniaturized optics, and microcentripetal forces, we have developed a simple “lab-on-a-chip” device on a compact disc (CD) platform that reads DNA of microbes and which allows the diagnosis of up to 8 infections simultaneously at POC in real time.
9:10 HIV Viral Load Testing from Centralized Laboratories to POC Options
Wendy Stevens, MBBch, MMed, FCPath, PI and SSALC Pathologist, Molecular Medicine & Hematology, National Health Laboratory Service and University of the Witwatersrand
9:40 POC: The Search for the Holy Grail Continues
Harry Glorikian, Founder and Managing Partner, Scientia Advisors LLC
There is significant room for improvement in POC diagnostics. The sensitivity of lateral flow strips is unsatisfactory and immunoassays are insufficient for critical care/emergency situations. Developing markets may expedite approval, but this would be limited to specific geographies and conditions. The Holy Grail remains elusive: Rapid antigen level TaT + MDx accuracy, multiplexing capabilities, integration to laboratory information management systems (LIMS), reasonable cost, and easy-to-use.
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10:10 Coffee Break
10:55 Chairperson’s Remarks
Sheldon Campbell, M.D. Ph.D. F.C.A.P., Department of Laboratory Medicine, Yale University School of Medicine
11:00 Infectious Disease Tests and Point-of-Care, an FDA Perspective
Francisco Martinez-Murillo, Ph.D., Staff Fellow, FDA CDRH
This talk will cover current FDA approaches to regulating rapid tests and testing algorithms based on rapid tests, particularly for detection of infectious disease when applied to point-of-care settings.
11:30 Evidence Required for the Effective Evaluation of a Diagnostic
Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious Agents, Technology Strategy Board
12:00 pm Use of Rapid Care Diagnostic Tests and Point-of-Care Diagnostics by Pharmacists
Michael E. Klepser, Pharm.D., FCCP, Professor of Pharmacy, Ferris State University
Pharmacists are uniquely positioned to identify patients early in the course of disease. The role of these tests and our experiences will be addressed.
12:30 Differentiating Your Lateral Flow Assay; High Sensitivity, Fluorescent Reader Based Assays with Enhanced Functionality
Brendan O’Farrell, Ph.D., President, Diagnostic Consulting Network, Inc.
Attendees will learn about the key features of quantitative, sensitive, fluorescent lateral flow assays and be introduced to a novel method for the generation of highly functional signals in lateral flow, including parallel lines, arrays, letters, numbers or symbols, yielding intuitive, easily interpreted signals, simplified multiplexing, and improved quantification.
12:45 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
2:00 Session Break
2:15 Chairperson’s Remarks
Christine C. Ginocchio, Ph.D., M. T. (ASCP), Hofstra University North Shore-LIJ School of Medicine
2:20 Overview and Impact of POC Testing
Bernard Branson, M.D., Medical Epidemiologist, Division of HIV/AIDS Prevention, Centers for Disease Control & Prevention
2:40 Antibody-Antigen Testing
Speaker to be Announced
3:00 POC HIV I and II Differentiation Assay
Kathleen Shriver, R&D Manager, Bio-Rad
3:20 POC Finger Stick Assay for Viral Load
Speaker to be Announced
3:40 Refreshment Break in the Exhibit Hall with Poster Viewing
4:05 Chairperson’s Remarks
Matthew Lorence, Ph.D., M.B.A., Senior Vice President, Marketing, Sales, and Business Development, TessArae, LLC
4:10 Access to Point-Of-Care HIV Diagnostics in Developing Countries
Randy Allen, Ph.D., Manager, Corporate Relations, Clinton Health Access Initiative (CHAI)
There is a need for cost-effective Point-of-Care (POC) diagnostics, especially in rural settings to improve access and reduce loss of follow-up of patients. POC products are already in the marketplace with others under development. Effective POC scale-up will depend on many factors and will vary significantly across countries.
4:40 Inexpensive Portable Molecular Diagnostic Instruments
Axel Scherer, Ph.D., Neches Professor of Electrical Engineering, Applied Physics and Physics, California Institute of Technology
We have developed and characterized inexpensive PCR instruments and interfaced these with automated sample preparation and read-out systems. Pathogen identification without intervention from skilled operators relies heavily on automation and we discuss the trade-off space of sample type, reagent shelf-life and cost.
5:10 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:10 Close of Day
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