FDA, CMS advocate new LDT oversight roles

In testimony before the House Energy and Commerce Subcommittee on Health, FDA's Jeffrey Shuren and CMS's Patrick Conway made the case for FDA to play a larger role in oversight of laboratory-developed tests (LDTs), citing the increased complexity and availability of the tests and their growing role in making diagnostic and treatment decisions.

Conway, CMS's CMO and deputy administrator for innovation & quality, said FDA "can play a critical role in premarket review" of LDTs, while CMS's staff does not have the scientific expertise to conduct premarket review. ...