Press Announcements > FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

Press Announcements > FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications 

Today, the U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) 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

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