Next Generation Dx Summit 2009 : Molecular Diagnostics for Infectious Diseases Day1

Ensuring the Safety and Validity of Molecular Diagnostic Tests

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

Bringing Point-of-Care HIV Diagnostics to Market: FDA Perspectives

Elliot Cowan, Ph.D., Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR

Sessions:

Gaining Regulatory Approval for Molecular Diagnostic Tests
Point-of-Care Molecular Tests for Detection of Infectious Disease
Quantitative PCR & Highly Multiplexed Assays
Microbe Hunting – Sequencing, Genotyping & Beyond
From Microbes to Fungal Pathogens
PCR and Point-of-Care Diagnostic Development – Viruses

Pre-conference Symposia

(SC1) CIRCULATING TUMOR CELLS AS SURROGATE ENDPOINTS IN CLINICAL TRIALS

(SC2) REALITY CHECK ON COMPANION DIAGNOSTICS

Scientific Advisory Board

Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious Agents, Technology Strategy Board

Christine C. Ginocchio, Ph.D., Director, Microbiology, Virology and Molecular Diagnostics, North Shore-LIJ Health System Laboratories

Daniel R. McClernon, McClernon, LLC

Tuesday, August 11

11:00am-12:00pm RegistrationPlenary Keynote Session

12:00pm Keynote Introduction and Opening Remarks

12:10 Ensuring the Safety and Validity of Molecular Diagnostic Tests

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

12:35 Q&A

12:45 Bringing Point-of-Care HIV Diagnostics to Market: FDA Perspectives

Elliot Cowan, Ph.D., Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR

Point-of-care diagnostics for human immunodeficiency virus are playing an important role in helping individuals know their HIV status. FDA is responsible for assuring that these products are safe and effective. This talk will address FDA’s expectations for the approval of rapid HIV tests, pitfalls in the process, and challenges posed by home use HIV test kits.

1:10 Q&A

1:20 Luncheon Presentation (Opportunity Available) or Lunch on Your Own

2:30 Chairperson’s Remarks

Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious Agents, Technology Strategy Board

2:40 Point-of-Care Diagnostics

Franklin R. Cockerill, III, M.D., Ann & Leo Markin Professor of Medicine and Microbiology, Consultant and Professor, Infectious Diseases and Internal Medicine, Mayo Clinic and Mayo Clinic College of Medicine; Chair, Laboratory Medicine and Pathology; President and Chief Executive Officer, Mayo Collaborative Services, Inc. (MCSI)

3:10 Bringing Molecular Diagnostics toward Point-of-Care in Developing Countries

Mark D. Perkins, M.D., Chief Scientific Officer, Foundation for Innovative New Diagnostics

Infectious diseases still account for a huge burden of disease in developing countries. Despite the fact that molecular testing offers speed and sensitivity, NAAT has had very little impact on clinical care of infectious diseases developing countries. This is primarily because of issues relating to the cost and complexity of the test methods, and the frailty of health systems. This talk will examine a recent model of phased development and implementation of simplified NAAT methods that bring infectious disease diagnosis to the point of care in disease endemic countries.

3:40 Multiplex Respiratory Virus Detection: Diagnosis, Infection Control, Epidemiology and Surveillance

Christine C. Ginocchio, Ph.D., M.T. (A.S.C.P., Director, Microbiology, Virology and Molecular Diagnostics, North Shore-LIJ Health System Laboratories, Lake Success, NY; Department of Microbiology and Genetics, School of Medicine, State University of New York at Stony Brook

Advances in the development of molecular-based pathogen detection systems have lead to the discovery of new respiratory viruses and have provided rapid, sensitive and accurate methods for viral diagnostics. The comprehensive identification of respiratory pathogens has allowed for a better understanding of the pathogenesis and clinical course of respiratory infections, differences and similarities in syndromes and the impact of co-infections. In addition, we now can study the true epidemiology of respiratory viral infections and can use this information to establish surveillance programs. This lecture will discuss the role of comprehensive respiratory virus detection for diagnosis, infection control, epidemiology, and bio-threat surveillance.

4:10 Networking Refreshment Break, Exhibit and Poster Viewing

4:45 The Critical Role of Controls and Calibrators in Molecular Infectious Disease Testing

David R. Hillyard, M.D., Professor, Pathology, University of Utah School of Medicine; Director, Molecular Infectious Disease Testing, ARUP Laboratories

5:15 Quantitative Assays for Diagnosis and Management of Infectious Diseases

Gregory A. Storch, M.D., Ruth L. Siteman Professor of Pediatrics, Professor of Medicine and of Molecular Microbiology, Director, Divisions of Pediatric Infectious Diseases and Laboratory Medicine, Department of Pediatrics, Washington University School of Medicine, Medical Director, Clinical Laboratories, St. Louis Children’s Hospital

This presentation will discuss the role of quantitative molecular testing in diagnostic virology. The emphasis will be on CMV, EBV, and BK virus. For CMV, the talk will address the role of quantitative testing in determining need for therapy, monitoring therapy, and detection of resistance to antiviral drugs. EBV is the main cause of post-transplant lymphoproliferative disorder (PTLD). This talk will discuss the relationship between viral load and PTLD. BK virus is the cause of transplant nephropathy in renal transplant recipients and hemorrhagic cystitis in hematopoietic stem cell transplant recipients. The talk will focus on the relationship between viral load and these clinical entities.

5:45 Questions from the Floor

6:00 Close of Day

Pre-Conference Symposia | Day 1 | Day 2