On January 18, 2023, the FDA and CMS made a joint statement rejecting the notion of expanding the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to oversee laboratory developed tests (LDTs).

“Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was stated in our 2015 testimony, CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense.”

The statement underscored the urgent need for accurate and reliable diagnostic tests in healthcare, emphasizing the crucial role of LDT validity for patients and doctors.

The FDA’s proposed rulemaking announced in October aims to overhaul the current approach to laboratory developed tests (LDTs), addressing concerns such as over- or under-treatment for heart disease, and incorrect cancer therapies, with passionate support expressed now from both the FDA and CMS.

The proposed changes aim to foster responsible competition, and incentivize science-based innovation in diagnostic test development. By aligning their oversight approaches, the FDA and CMS aim to reassure patients and healthcare providers that LDTs adhere to high standards of safety and efficacy, addressing the evolving challenges in the landscape of diagnostic testing.

The joint statement underscores the commitment of both the FDA and CMS to have the FDA regulate all In Vitro Diagnostics (IVDs), including LDTs, rather than expanding oversight via CLIA. While some have voiced concerns about the specific approach taken by the FDA, we advise the IVD industry and clinical laboratories to proactively plan for these anticipated changes.

For more information, see our summary on the proposed FDA regulation of LTDs.