2013 Archived Content
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WEDNESDAY, AUGUST 21
11:00 am Registration
11:00 PLENARY KEYNOTE DISCUSSION
Perspectives on Evaluating Novel Diagnostics for Reimbursement
Moderator: Andrew C. Fish, Executive Director, AdvaMedDx
- Levels of evidence needed to support novel diagnostics
- Health economics
- Analytical issues
- MS policy
- Rate schedule
Aaron D. Bossler, M.D., Ph.D., Clinical Assoc. Prof., Dir., Mol. Pathology Lab and Molecular Genetic Pathology Fellowship Program, University of Iowa Hospitals and Clinics and Co-Chair, AMP Economic Affairs Committee
Dwight Denham, MBA, Director, Clinical Research, Beckman Coulter, Inc.
Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA
Lee H. Newcomer, M.D., Senior Vice President, Oncology, United Healthcare
12:30 pm Enjoy Lunch on Your Own
1:50 Chairperson’s Opening Remarks
Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology and Medicine, Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic
2:00 Featured Presentation: Integrating Rapid Pathogen Identification, Susceptibility Testing, and Antimicrobial Stewardship Significantly Decreases Hospital Costs
James M. Musser, M.D., Ph.D., Fondren Distinguished Endowed Chair; Pathology and Genomic Medicine, The Methodist Hospital System; Dir., Ctr for Mol. and Translational, Human Infectious Diseases Research, The Methodist Hospital Research Institute
We used bloodstream infections to test the hypothesis that integrating rapid pathogen identification by mass spectrometry, susceptibility testing, and antimicrobial stewardship significantly decreases hospital costs. In our 1,000-bed quaternary hospital, the altered work flow resulted in substantial annual cost savings. We recently added targeted full-genome sequencing of infecting organisms to this re-engineered platform.
2:25 Featured Presentation: Use of Outcome Data to Justify the Implementation of New Technology into the Clinical Laboratory
Susan M. Novak-Weekley, Ph.D., D(ABMM) Director, Microbiology, Southern California Permanente Medical Group Regional Reference Laboratories
The challenge in the health care today, more so than ever before, is to provide affordable, quality care to patients. The use of outcome data to drive decisions in the laboratory is extremely important to help administration understand why new technology should be incorporated into the laboratory setting and how that technology impacts the patient.
2:50 Assays for the Detection of Bacteremia and Their Impact on Patient Care
Karen C. Carroll, M.D., Professor of Pathology and Medicine; Director, Division of Medical Microbiology, The Johns Hopkins University School of Medicine
A variety of assays are available to speed the identification of pathogens in positive blood cultures. These assays may have an impact on patient outcomes and reduce healthcare costs.
3:15 Infectious Disease Testing with the Verigene System: Multiplex Assays for Blood Cultures and Enteric Pathogens
Teresa Raich, Ph.D., Vice President, Clinical & Scientific Affairs, Nanosphere, Inc.
Nanosphere's FDA-cleared Verigene System enables rapid molecular testing for infectious diseases in a near-patient setting. Cartridge-based multiplexed tests for bloodstream infections, GI infections, and respiratory tract infections provide physicians with comprehensive, time-critical results that allow for real-time optimization of patient treatment.
3:30 Impact of a Multiplex Molecular Diagnostic Panel for Rapid Identification of the Causes of Infectious Gastroenteritis
Jeff Hester, Ph.D., Vice President, Research & Development, Viracor-IBT Laboratories
Infectious gastroenteritis is a common illness that is challenging for both appropriate patient management and contributes to significant health economic costs—particularly within the hospital system. A novel multiplexed molecular diagnostic assay to detect the most frequent bacterial, viral and parasitic causes of the illness in less than a day will be presented and discussed and compared to traditional microbiological methods.
4:00 Refreshment Break in the Exhibit Hall with Poster Viewing
4:30 Highly Multiplexed Microbiology Devices – Performance Validation Challenges and Solutions
Uwe Scherf, M.Sc., Ph.D., Deputy Director, Division of Microbiology Devices, Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health, U.S. Food and Drug Administration
Highly multiplexed microbiology in vitro diagnostic devices present several advantages. However, establishing and validating the performance of these devices to make informed clinical and public health decisions pose significant scientific challenges. The talk will present recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiology in vitro nucleic acid based diagnostic devices.
5:00 The Future of Point of Care Testing: Moving Diagnostics to “Point-of-Impact”
Christine C. Ginocchio, Ph.D., MT (ASCP), Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, Department of Pathology and Laboratory Medicine and Department of Molecular Medicine, Feinstein Institute for Medical Research, North Shore-LIJ Health System, Professor, Hofstra North Shore-LIJ School of Medicine, NY
The current economics of healthcare has led to many laboratory consolidations and centralization of testing, affording financial savings and expanded testing services. However, appropriate clinical care remains imperative. Results must be provided within a time frame that impacts patient care and outcome. To meet this goal, laboratories must now also consider a reversal from centralization to decentralization of critical testing to the appropriate “point of impact”. New rapid simple technologies that meet this goal and the potential financial and clinical benefits of point of impact testing will be discussed.
5:30 Rapid Diagnosis of Infectious Diseases in Decentralized Clinical Settings
John Clarkson, Ph.D., CEO, Atlas Genetics
Systems for use in decentralized clinical settings such as the hospital ER, specialist primary care clinics and physicians’ office laboratories need to be rapid, accurate, simple to use and cost effective. This presentation will overview recent developments in this area, and explore the benefits of point-of-care tests for sexually transmitted infections.
5:45 Bringing an OTC Home Use Rapid HIV Test Kit to Market
Elliot P. Cowan, Ph.D., Former Chief, Product Review Branch, Center for Biologics Evaluation and Research, Principal, Partners in Diagnostics, LLC
This talk will describe the role of risk assessment, in addition to sensitivity and specificity, in the determination of safety and efficacy for the first approved over-the-counter home use rapid HIV test kit. This approach takes into account both the public and individual health impacts.
6:00 Dinner Short Course Registration
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