FDA Oversight of LDTs Delayed for Consultation with New Administration, Stakeholders

The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its laboratory-developed test (LDT) guidance document before the end of the year. In fact, the FDA confirmed Friday that it will instead work with the new administration on appropriate reforms to ensure LDTs are safe and effective. According to a statement from the FDA, which G2 received in response to a request for confirmation of the status of the guidance document: “The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.” Agency representatives had previously indicated an intent to release before the end of […]