FDA Delays Finalization of Lab-Developed Test Draft Guidance

The FDA said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated. Tara Goodin, press officer for FDA told Focus: “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.” Roger Klein, chair of the professional relations committee at the Association for Molecular Pathology, told Focus: “FDA’s decision to delay release of a final LDT guidance is in the best interest of patients and providers, and supports further advancement in molecular pathology testing. We look forward to working with the FDA as we find ways to continue to improve the already high-quality testing that we provide to patients.” The American Clinical Laboratory Association also  praised the move, with president Alen Mertz calling the decision “a victory for diagnostic innovation and most importantly, patients.”