FDA Warns Lab Against Marketing Tests Linking Genes, Drug Reaction

Megan Brooks

Disclosures

April 05, 2019

The US Food and Drug Administration (FDA) has warned Inova Genomics Laboratory over illegal marketing of MediMap pharmacogenetic tests that claim to predict patients' response to a variety of drugs, including those used for anesthesia and to treat cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes.

The warning letter said the following tests are being marketed without clearance or approvals: MediMap ADHD, the MediMap Mind, the MediMap Plus, the MediMap Heart, and the MediMap Baby.

The FDA has not reviewed the safety and effectiveness of the tests, and selecting or changing drug treatment in response to results from the tests could lead to "potentially serious health consequences for patients," the agency said in a statement.

The FDA said it knows of no data that establish that the company's tests can help patients or healthcare providers make appropriate treatment decisions regarding the listed drugs.

"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," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the statement.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said the FDA is "committed to supporting innovation" in pharmacogenetic testing but will also be "vigilant in protecting against the potential risks and are therefore issuing this warning letter to help protect patients and providers from acting on data that has not been demonstrated to promote the safe and effective use of drugs."

Inova Genomics, of Falls Church, Virginia, has 3 weeks to notify the FDA in writing regarding how it will address the violations. Failure to do so may result in regulatory action that could involve seizure, fines, or injunctions.

Last year, the FDA warned consumers and healthcare providers about pharmacogenetic tests being marketed directly to consumers or being offered through healthcare providers that claim to predict how a patient will respond to specific medications.

Healthcare providers are encouraged to report any adverse events related to these or other genetic tests to MedWatch, the FDA's safety information and adverse event reporting program.

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