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THURSDAY, JUNE 25, 2015
5:30-8:30 pm | DINNER WORKSHOP


How to Launch a Laboratory Test: Everything You Wanted to Know But Were Afraid to Ask

The workshop is designed to give a clear and complete overview / as well as guidance for any company or researcher who is planning to bring a molecular test to the market. In this session, the instructors will begin with a discussion covering FDA approval pathways, recent updates to molecular diagnostics regulations, the different levels of evidence that drive FDA approval and payer coverage, reimbursement fundamentals and the latest coding updates and laws that will impact coverage and payment across the diagnostics industry.

Following the presentation will be an interactive case study activity for participants to exercise their new knowledge of regulatory and reimbursement considerations for diagnostic tests. Participants will work together to determine whether diagnostic test cases would or would not have successful commercialization and why, and finally regroup to discuss the actual outcomes.

Topics to be covered include:

  • Analytical validity, clinical validity and clinical utility
  • CLIA certification
  • FDA approval
  • Third party payers – CPT coding and reimbursement/billing

Instructors:

Steven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc.

Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP


About Instructors: 

Steven-GutmanSteven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc.  

Steve has more than 30 years of medical industry experience with 15+ years at FDA, where he founded and directed OIVD, the Office of In Vitro Diagnostics. Steve holds a deep understanding of IVD history and regulation from developing policy and representing the agency for many years. Steve comes to Myraqa from Blue Cross Blue Shield Association, where he has been extending his scope of work as an Associate Director, where he formed scientific valuations and policies. Steve earned his MD at Cornell University Medical College, MBA with distinction from SUNY at Buffalo and his BS from The Ohio State University.

Blog Posts by Steve Gutman, MD 

Bruce QuinnBruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP 

Bruce Quinn, M.D., Ph.D., is a national expert on medicare policy, the impact of health reform on innovation and the crafting of successful business strategies within the U.S. healthcare reimbursement system Dr. Quinn has worked successfully with both large and small companies in overcoming hurdles to commercialization through negotiation, understanding insightful ways to use the existing systems to advantage and the mechanisms of policy change. Since 2008, he has been a full time business strategist working with attorney and policy teams for healthcare and life sciences clients in the firm's Government Strategies practice. 

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