Gottlieb: Congress Should Regulate LDTs, LDT Community Should Rethink Marketing

FDA Commissioner Scott Gottlieb said that Congress should legislatively lay out the government's role in overseeing diagnostic tests, and that the broader diagnostic testing community should work together to understand how to commercialize tests so they better benefit patients. Gottlieb’s comments came during Friends of Cancer Research’s “A Blueprint for Breakthrough” event last Wednesday (Sept. 13). During the event, Gottlieb fielded questions from attendees regarding FDA’s current thinking on an oversight system for diagnostic tests. The agency chief said that...