FDA WARNING_LETTER - Inova Genomics Laboratory - April 04, 2019

On April 4, 2019, the FDA issued a Warning Letter to Inova Genomics Laboratory for marketing the MediMap ADHD, MediMap Mind, MediMap Plus, MediMap Heart, and MediMap Baby tests without marketing clearances or approvals, violating the Federal Food, Drug, and Cosmetic Act. The FDA classified these MediMap tests as devices intended for diagnosis, treatment, or affecting body function.

The firm's website markets these genetic tests for predicting medication response, reducing side effects, and guiding drug and dosage selection. The FDA expressed concern that the clinical validity of these tests for their intended uses has not been established, citing a lack of data supporting genotype-drug response relationships for multiple drugs, such as escitalopram and sertraline.

The FDA highlighted significant public health concerns, as inaccurate results could lead to inappropriate treatment decisions, including incorrect dosing, ineffective therapies, or withholding beneficial treatments, potentially causing serious health consequences, illness, injury, or death. The letter also noted that direct patient reporting of results could lead to unsafe self-medication changes.

Inova Genomics Laboratory declined to commit to changes, asserting the tests are Laboratory Developed Tests (LDTs) exempt from FDA premarket review. The FDA clarified that no legal exemption for LDTs exists and that while it generally exercises enforcement discretion, it retains the right to act on significant public health concerns.

The MediMap tests are deemed adulterated under section 501(f)(