FDA warns lab for falsely advertising a test that predict patients' responses to specific medications

April 5, 2019

Yesterday afternoon the Food and Drug Administration issued a warning letter to Inova Genomics Laboratory of Falls Church, VA, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. FDA says it has no data on record supporting the company’s claim that the test can predict patients’ responses to specific medications based on genetic variants and people who use and rely on the test results could be putting their health in jeopardy.

The agency says such tests can be harmful either by influencing physicians to not prescribe a drug that could actually help a patient’s particular health condition or prescribe a treatment that isn’t appropriate, based on false predictions.

“Without appropriate evaluation to determine whether these tests work, patients are being put at risk - potentially impacting treatment decisions by providing false promise that they will respond well to a certain medicine or keeping them from using therapies that may benefit them,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We are particularly concerned about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established and are not described in the drug labeling and continue to warn patients and health care professionals that they should not rely on these tests for treatment decisions.”

Inova is being warned for marketing pharmacogenetic tests for specific named drugs, including antidepressants, opioids, cancer treatments, anesthesia and diabetes medications. The FDA states that it has not reviewed any of these tests nor does it have any data regarding their efficacy or safety The warning letter requests that Inova respond, within 15 working days from the date the warning letter was received, with details of how the violations noted in the warning letter will be corrected. Any violations not corrected could lead to enforcement action such as seizure, injunction or civil money penalties.