On April 4, 2019, the U.S. Food and Drug Administration issued a Warning Letter to Inova Genomics Laboratory (“Inova”) for marketing pharmacogenetic tests without FDA clearance or approval. In the letter, the FDA reiterates its position that the agency has not created a legal “carve-out” for laboratory developed tests (LDTs), and although the agency has generally exercised enforcement discretion, the agency “always retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns.”

Clinical laboratories reviewing their LDT marketing materials, test menus, test reports, and other labeling should be cognizant of the FDA’s past compliance activities and the concerns cited that have led to initiation of enforcement action. Concerns cited by the Warning Letter to Inova include:

  • Inaccurate test results for the claimed indications for use could impact decision-making in ways that are seriously detrimental to patient health.
  • Claims of clinical validity of the tests that have not been established for the intended uses.
  • The relationship between the genotypes assessed and the claims regarding drug response are not described in the FDA-approved labeling for the drugs.
  • Test results may be provided directly to patients, which may lead to inappropriate dose adjustment of medication without physician involvement.

Stakeholders should also stay apprised of discussions on draft legislation seeking to modernize regulation of diagnostics, as such discussions may provide further clues as to the FDA’s enforcement priorities. Notably, the concerns identified in the Warning Letter to Inova parallel those applicable to tests that the FDA has repeatedly identified as requiring a higher degree of oversight.  For example, in technical assistance provided on the preliminary discussion draft of the Verifying Accurate Leading-edge IVCT Development Act of 2018 (the “VALID Act”), the FDA identified the following as tests that would generally need individual premarket review under the new framework contemplated by the draft bill:

  • High-risk tests
  • Novel tests
  • Tests that are cross-labeled for use with a drug or other therapeutic product, or
  • Tests that are marketed direct-to-consumer or for home use

On May 3, 2019, industry groups representing patient advocates, providers, laboratories, and diagnostic manufacturers urged Congress in a letter to hold public forums to discuss revisions to the VALID Act discussion draft and to finalize changes by year’s end. Clinical laboratories should, at minimum, closely monitor the discussions with an eye for the potential impacts upon marketing of current offerings and tests in the pipeline.

  • Steven Tjoe

    Steven Tjoe is a FDA Senior Associate, FDA Counseling Group at Goodwin. Steven advises drug, biotech, medical device, and diagnostic developer clients on a range of FDA regulatory matters, including product development strategies, lifecycle management & competition issues, advertising & promotion issues, and regulatory compliance. Prior to joining Goodwin, Steven served as regulatory counsel at FDA’s Center for Devices and Radiological Health.


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