Laboratory-Developed Test Oversight FAQs

April 2, 2019

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.

The CAP opposed the DAIA legislation because it included provisions irrelevant to LDT oversight and it utilized a regulatory structure that was overly complex. DAIA sought to open CLIA and subject laboratories to regulations and scrutiny that would stifle innovation of tests, including those at the lowest level of risk. For smaller and rural laboratories, DAIA sought to create another layer of regulatory complexity and burden for laboratories that still need to operate under current CLIA requirements.

Compared to the DAIA bill, the draft VALID Act omits extraneous provisions to reopen CLIA and focuses on the oversight of LDTs. Excluding extraneous CLIA provisions from the VALID Act is a positive step forward. Although the VALID Act takes a focused and material approach to LDTs, the CAP is still concerned with certain aspects of the bill and provided its comments to the bill’s sponsors in February 2019. The CAP seeks to engage with the legislative sponsors to discuss these provisions and address concerns.

The CAP is seeking clarification on certain aspects of the VALID Act. For example, the CAP is concerned with quality system requirements, which appear to be duplicative, costly, and burdensome because laboratories would need to implement new processes and procedures as well as hire additional staff. The CAP also questions application of a precertification program that is narrowly focused on low-risk tests and would be applicable to a relatively small number of tests. By broadening precertification, the program would be applicable to a larger number of tests and would further reduce regulatory burden.

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.

During the Obama and Trump administrations, FDA jurisdiction regarding regulation of LDTs has been clearly outlined in the FDA oversight proposals and communications – including in draft LDT guidance (2014) and a discussion paper (2017). With the current administration deferring to Congress, the CAP advocates for the government to minimize burden on laboratories. This can be achieved through coordination between the FDA and the CMS to eliminate duplicative requirements.

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.