Laboratory-Developed Test Oversight FAQs

December 9, 2021

Laboratory-Developed Tests

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The CAP’s longstanding principles for LDT oversight are:

  • Ensure quality laboratory testing for patients.
  • Allow for innovation in laboratory testing.
  • Prevent undue administrative or regulatory burdens on laboratories.

The CAP’s policy on LDT oversight includes a tiered risk-based approach that allows for evaluation of patient risk based on a laboratory’s claims for the test and potential harm of an incorrect or misinterpreted test. Legislation also should include a grandfather provision and encourage coordination between federal agencies to avoid duplicative and unduly burdensome requirements on laboratories.

Current oversight requirements governing LDTs are the laboratory requirements prescribed in CLIA. The FDA claims jurisdiction for the oversight of LDTs and exercises an enforcement discretion policy at this time. The FDA has not finalized a plan to regulate LDTs but defers to Congress to draft legislation to address this issue.

A legislative plan for LDTs must focus on protecting patients and providing access to safe diagnostic tests with an oversight framework that is the least burdensome for laboratories. Extraneous provisions included in legislation interfere with goals of ensuring quality tests for patients.

Compared to previous efforts to legislate on LDT oversight, the current version of the VALID Act omits extraneous provisions to reopen CLIA and focuses on the oversight of LDTs. Excluding extraneous CLIA provisions from the VALID Act was a positive step forward. As the CAP has engaged with the bill’s sponsors through the years, the VALID Act continues to move in the right direction and provides the most viable legislative pathway to reaching a consensus on the oversight of LDTs. A legislative approach to oversight of LDTs must leverage existing processes to maintain safe and reliable testing for patients today without stifling innovation of future tests.

The CAP has recommended ways to streamline the VALID Act to make it nimbler and less burdensome to implement. The CAP’s comments on the legislation have focused on three specific areas: operationalization, risk classification, and modifications.

The VALID Act provides a better foundation for any future legislative proposal since its focus remains on LDT oversight rather than extraneous CLIA modifications. The VALID Act leverages existing processes, which may help mitigate cost and reduce burdens for laboratories when implementing an oversight framework. The CAP also appreciates that the VALID Act will not attempt to regulate the practice of medicine.

No. The FDA has deferred to Congress. In January 2017, the FDA issued a discussion paper on LDTs to advance the public discussion and spur further dialogue on oversight of LDTs.

The most viable legislative proposals in Congress have outlined FDA oversight for LDTs. The current presidential administration supports these efforts.

With our field evolving quickly, the CAP supports an exception to the Administrative Procedures Act so regulatory guidance can be utilized for an LDT oversight framework instead of the traditional rulemaking process. We believe use of the rulemaking process will stifle innovation and lead to rigid regulatory constraints in a time of rapid technology development and evidence generation.