Segment 4: The FDA Takes Initiative to Regulate the Diagnostic Test Market

John Fox, MD, MHA, wondered if the FDA’s announcement that it will begin to regulate laboratory-developed tests being marketed will limit the number of people who develop tests and help clean up the market.

Daniel F. Hayes, MD, hopes that will be the case and he is happy with the FDA initiative and how responsibly the agency has approached beginning to regulate the field.

“There’s a great deal of concern that this will squash innovation and dampen down new test development,” he said. “I think it might have the opposite [effect].”