This panel will consider the effect of regulation on the appropriate use of genetic testing and their integration into healthcare. It will examine the challenges of regulating an industry with several agencies overseeing various aspects, and growth in genetics exceeding the capacity of the expertise of the oversight agencies. Are there gaps in oversight between FDA and CLIA and if so, how do they affect patients? How can they be addressed?
Moderator: Sheila Walcoff, Goldbug Strategies
Alberto Gutiérrez, FDA
Paul Radensky, McDermott Will & Emery
Alan Mertz, American Clinical Laboratory Association
Russell Enns, Cepheid.