Over 30 disease advocacy groups wrote to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schemer (D-NY) Tuesday (Jan. 24) urging Congress to work with FDA to craft a regulatory framework for laboratory developed tests (LDTs). The groups argued that increasing LDT complexity warrants analytical validity oversight, which they feel is lacking from CMS’ lab-oversight program under CLIA. The push comes as laboratories generally argue that FDA shouldn’t play a role in overseeing LDTs.

FDA announced in November that it would not finalize a controversial plan for LDT oversight, which would have required notification, approval and reporting requirements for laboratories. However, FDA on Jan. 13 released a discussion paper outlining a possible path forward on LDT oversight that would give both CMS and FDA a place in regulating the tests, and would grandfather in all previously marketed LDTs. Tuesday’s letter makes no mention of the FDA proposal.

“The undersigned organizations, representing patients, scientists, advocates, caregivers and health care professionals, urge you to make updating the oversight framework for all molecular diagnostic tests, including laboratory developed tests (LDTs), a priority early in the 115th Congress. We also believe strongly that FDA should play a critical role in a modernized framework that supports patient safety and access to valid tests,” the groups write.

The groups argue that with increasing complexity of molecular tests, FDA’s lack of oversight has become outdated. “Originally, the rationale for lack of FDA premarket review for LDTs was that the tests were relatively simple — like Pap smears — and generally done within the same facility where the patient was treated. As science and technology have progressed, tests are increasingly being sent to centralized labs, and the development and complexity of LDTs has grown substantially. As a result, tests that play a direct role in determining the care patients receive currently circumvent oversight,” the letter states.

A CMS-only regulatory framework for LDTs wouldn’t provide acceptably comprehensive analytical validation, the groups argue. “[A]nalytical validation of LDTs under CLIA is not as comprehensive as that required by FDA, and is not designed to ensure consistent performance for measuring the same analyte across laboratories. Moreover, CLIA does not evaluate the clinical validity of a test, i.e., the test’s ability to detect the clinical condition for which the test is intended. FDA oversight of tests — including premarket review for high-risk tests — is critical to ensuring the analytical and clinical validity of LDTs,” the groups write.

FDA’s Jan. 13 discussion paper cited similar arguments for not relying solely on CLIA oversight of LDTs. “Adapting CLIA to enable CMS to provide the kind of effective oversight of LDTs that is needed to ensure that they are accurate, reliable, and clinically valid would require a significant change in the nature of what the agency does, rather than minor modifications as some have suggested. By its very nature, a CMS-only framework for LDTs could create costly federal redundancies and inefficiencies,” FDA wrote.

Signers of Tuesday’s letter include Friends of Cancer Research, American Cancer Society Cancer Action Network, American Heart Association, The ALS Association and US Pain Foundation. 

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