FDA Won’t Release Final LDT Guidance in 2016

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:

“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Agency representatives had previously indicated an intent to release before the end of 2016 a final version of the 2014 draft guidance document. That guidance set forth a framework for FDA oversight of LDTs.

The American Clinical Laboratory Association, which had vigorously opposed the draft framework, commended the agency’s decision to work with lawmakers on LDT reforms. “We appreciate the FDA’s acknowledgment that stakeholder input and the ongoing bipartisan work carried out in the House and Senate is the appropriate process to advance comprehensive statutory reform of the LDT regulatory framework,” said ACLA President Alan Mertz in a statement. “Today’s announcement by the FDA has paved the way for a transparent discussion on meaningful reform that would protect diagnostic innovation and patient access.”