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WEDNESDAY, AUGUST 22
11:00 am Registration
» 11:50 PLENARY KEYNOTE DISCUSSION
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
» PLENARY KEYNOTE
1:45 Position of IVDs on Regulatory Issues
Alan Mertz, President, American Clinical Laboratory Association (ACLA)
2:10 Diagnostic Manufacturers: Key Regulatory Issues
Andrew C. Fish, Executive Director, AdvaMedDx
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2:30 Refreshment Break in the Exhibit Hall with Poster Viewing
3:15 Chairperson’s Opening Remarks
Nathan A. Ledeboer, Ph.D., Assistant Professor of Pathology, Medical College of Wisconsin
3:20 SPOTLIGHT PRESENTATION: Innovative Technologies from Mass Spec to Multiplex Technologies
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 North Shore-LIJ Health System Laboratories
Global travel, the spread of re-emerging infectious diseases and the threat of new pandemics highlight the need for comprehensive and sensitive pathogen detection. Identification of the infectious agent(s) is essential to provide an accurate diagnosis, appropriately manage patient care, including the use of antimicrobial agents, and in certain cases reduce the risk of transmission within the community and health care settings. To meet these challenges, innovative technologies have been developed that detect single pathogens, multiple syndromic related pathogens and genotypic drug resistance. This lecture will provide an overview of new technologies including unit test systems designed for point of care diagnostics, arrays, droplet digital PCR, and mass spectroscopy analysis. Unmet diagnostic needs, regulatory challenges and future considerations will be discussed.
3:50 Advancing Diagnostics...Saving Lives: How Rapid Diagnostic Microbiology Can Make a Difference
Donna M. Wolk, M.H.A., Ph.D., D.(ABMM), Division Chief, Clinical and Molecular Microbiology; Associate Professor, Pathology and Medicine, Arizona Health Science Center and University Medical Center
Over the last decade, the Medical Diagnostic Laboratory Sciences community gained access to the proliferation of new and rapid diagnostic technology, largely based in the fields of genomics and proteomics. With access to emerging technology comes the responsibility for prudent stewardship of healthcare resources, supported by the application of evidence-based interventions that encompass the contemporary practice of Laboratory Medicine. This session will review the applications of mass spectrometry in clinical microbiology and describe its implementation in an academic medical center.
4:20 Sponsored Presentation
Speaker to be Announced, Luminex
4:35 Randox Biochip Array Technology: A Revolutionary Step in Multiplex Oncogene Mutation Screening
Scott McKeown, Ph.D, R&D Consultant, Randox Laboratories Ltd.
Randox have developed award-winning Biochip Array Technology (BAT) for rapid proteomic, and most recently, genomic diagnostics across a range of human diseases. Utilizing multiplex PCR, spatially tethered specific probes and chemiluminescence detection methods, our innovative array simultaneously identifies 20 mutations across KRAS, BRAF and PIK3CA oncogenes within 3 hours.
4:50 PCR-ESI-TOF-MS-Based Diagnostics Provide Unprecedented Sensitivity, Specificity, and Inclusivity in the Detection and Characterization of Infectious Diseases
Garth D. Ehrlich, Ph.D., Executive Director, Center for Genomic Sciences, Allegheny-Singer Research Institute
We have used the Ibis technology in multiple comparative studies with culture to evaluate the bacteriology of numerous infectious and inflammatory conditions including: total joint failures; osteoarthritis, bony non-union, ACL-repair failure, chronic non-healing wounds, vaginal and uterine microbiomes and infections, urinary and male genital tract infections, and surgical site infections.
5:20 Digging Deeper: Improving Results through Detailed Analysis of MALDI-TOF Data
Mark Fisher, Ph.D., Assistant Professor of Pathology, The University of Utah, ARUP Institute for Clinical and Experimental Pathology
MALDI-TOF is rapidly becoming an accepted identification method in the clinical microbiology laboratory. Current platforms accurately identify a broad range of organisms, but yield ambiguous results for some clinically relevant pathogens. Detailed analysis of the data at both the scoring and spectral levels can allow for better resolution and more reliable results.
5:50 Close of Day
6:30- 8:30 pm Dinner Short Courses*
*Separate registration required
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