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# FDA Warns Inova Genomics Lab on Illegal Genetic Tests
- URL: https://www.fdaweb.com/fda-warns-inova-genomics-lab-on-illegal-genetic-tests/
- Published: 2019-04-04T12:00:00.000Z
- Updated: 2026-09-15T01:18:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143797

FDA has issued a [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634988.htm?ref=fdaweb.com) to Inova Genomics Laboratory for illegally marketing certain genetic tests that have not been reviewed by FDA for safety and effectiveness. An agency media [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635283.htm?ref=fdaweb.com) says the tests claim to predict patients’ responses to specific medications based on genetic variants. “Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients,” the statement says.

The agency says it is unaware of any data establishing that Inova’s tests can help patients or healthcare providers make appropriate treatment decisions for the listed drugs.

According to the Warning Letter, FDA notified Inova of its concerns in a 3/13 teleconference and asked the company to change its MediMap tests and labeling to address the concerns outlined in an 11/2018 FDA [safety communication](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624794.htm?ref=fdaweb.com), including removing from the labeling claims regarding drug responses for specific medications unless and until FDA reviews the information submitted to support such claims and grants marketing authorization.

Inova, the agency says, declined to commit to such changes. The company said that the MediMap tests are laboratory-developed tests and that “Inova believes it is properly operating within the scope of FDA’s laboratory-developed test (LDT) exemption and thus is not subject to FDA’s premarket review or labeling requirements.”

In the letter, FDA says it has not created a legal carve-out for LDTs such that they are not required to comply with the requirements under the Federal Food, Drug, and Cosmetics Act that otherwise would apply. “FDA has never established such an exemption,” the letter says. “As a matter of practice, FDA, however, has exercised enforcement discretion for LDTs, which means that FDA has generally not enforced the premarket review and other FDA legal requirements that do not apply to LDTs. Although FDA has generally exercised enforcement discretion for LDTs, the agency always retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns.”

The agency then says it has determined that the MediMap tests are adulterated and misbranded.

Inova was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each of the actions and a calendar for completion.