Advanced Molecular Diagnostics: Reforming Regulation and Reimbursement

Original air date June 30, 2011 -- Presented by the 2011 BIO International Convention

Personalized medicine and advanced diagnostics could transform healthcare, but regulation under laws and policies require reexamination or reformation in the U.S. Already underway, this multilateral process is complicated by competing visions of "right-sizing" such regulation, overlapping agency and federal-state jurisdictions, competing public health priorities, limited resources and market and payor pressures on innovation. The panel will look ahead and provide an overview of the prospects for changes in the regulation and reimbursement of advanced molecular diagnostics (Dx).


  • Bruce Quinn, M.D., Ph.D., MBA, Senior Health Policy Specialist, Foley Hoag LLP (Moderator)
  • Sharon Terry, President and Chief Executive Officer, Genetic Alliance
  • Courtney Harper, OIVD Associate Director of Toxicology, U.S. Food and Drug Administration