Community Letter Urging Congress to Enact Diagnostic Oversight Reform

May 29, 2018

Leading health care companies and organizations representing patients, providers, laboratories and diagnostic manufacturers called on Senate and House leaders to advance legislation that would reform and modernize the process for bringing innovative diagnostics and clinical laboratory tests to market. In a letter to the Chairmen and Ranking members of the Senate Committee on Health, Education, Labor & Pensions (HELP) and House Energy and Commerce Committee, more than 80 organizations urged Congress to prioritize meaningful diagnostic oversight reform in 2018, including for laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).

The call for action represents the first time manufacturers, providers, labs, and patient groups have come together to make a collective push for clinical diagnostic regulatory reform and comes on the heels of recent public comments from Food and Drug Administration (FDA) Commissioner Scott Gottlieb stating comprehensive legislative action on clinical laboratory diagnostics is timely and appropriate.