Genome-Based Diagnostics Clarifying Pathways to Clinical Use: Workshop Summary (2012) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 63-68
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Appendix A Workshop Agenda Facilitating Development and Utilization of Genome-Based Diagnostic Technologies: A Workshop November 15, 2011 The Keck Center of the National Academies 500 Fifth Street, NW Washington, DC 20001 WORKSHOP OBJECTIVE To address the differences in evidence required for clinical use, regulatory oversight, and coverage for a laboratory test, as well as laboratory test reimbursement, with the goal of clarifying a pathway for successfully bringing a test to clinical use for the benefit of patients. Focal Questions: • What are your views of the described barriers to successful genomic test development?
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CLINICAL GENOMIC DIAGNOSTICS -- PART I Moderator: Robert McCormack, Veridex, LLC Daniel Hayes Clinical Director of the Breast Oncology Program and Stuart B Padnos Professor in Breast Cancer Research, University of Michigan Comprehensive Cancer Center Muin Khoury Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention
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CLINICAL GENOMIC DIAGNOSTICS -- PART II 12:00 P.M. Moderator: Debra Leonard, Weill Cornell Medical Center Steven Shak Chief Medical Officer, Genomic Health, Inc.
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ADVANCING MOLECULAR DIAGNOSTICS THROUGH REGULATORY AND REIMBURSEMENT POLICY Moderator: Debra Leonard, Weill Cornell Medical Center Alberto Gutierrez Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration Louis Jacques Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services 3:20-3:30 P.M.
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Robert McCormack, Workshop Co-Chair Head of Technology Innovation and Strategy, Veridex, LLC Debra Leonard, Workshop Co-Chair Professor and Vice Chair, Department of Pathology and Laboratory Medicine; Director of the Clinical Laboratories; Weill Cornell Medical Center ADJOURN 6:00 P.M.
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