FDA issued a warning letter to Inova Genomics Laboratory of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. 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 FDA is unaware of any data establishing that Inova’s tests can help patients or health care providers make appropriate treatment decisions for the listed drugs.
The action today reflects the agency’s commitment to monitor the pharmacogenetic test landscape and take action when appropriate to address a significant public health risk.
That letter can be found here.
When the agency has reviewed scientific evidence demonstrating a sufficient relationship between the drug’s effects and genetic variants, information about using genetic test results to manage medication treatment will be described in the labeling.
