FDA clears 23andMe for pharmacogenetics testing

The FDA recently cleared a pharmacogenetic DNA test from 23andMe that is designed to determine how users will react to certain pharmaceutical drugs.

The FDA cleared the new 23andMe test to give information on 33 genetic variants that determine how patients will respond to more than 50 different prescribed and over-the-counter medications. The test, which involves spitting into a tube and sending it back to the company, will look at how patients will be able to metabolize certain medications.

“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their healthcare providers. We know that consumers are increasingly interested in genetic information to help make decisions about their healthcare,” Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release.

23andMe’s new test is the first direct-to-consumer report on pharmacogenetics to be authorized by the FDA through the de novo classification process.

“We’ve continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information,” said 23andMe co-founder and CEO Anne Wojcicki. “Pharmacogenetic reports are an important category of information for consumers to get access to and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications.”

The FDA reviewed the test by asking the company to provide data to show that the test is accurate and can provide reproducible results.

“This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice and does not diagnose any health conditions,” said Stenzel. “Consumers should not use this test to make treatment decisions on their own. Any medical decisions should be made only after discussing the results with a licensed healthcare provider and results have been confirmed using clinical pharmacogenetic testing.”

However, the FDA is also warning the public about pharmacogenetic tests that have not been reviewed by the FDA.

“Specifically, we are warning consumers about many such genetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications. Tests that make such claims that have not been evaluated by the FDA and are not supported by prescribing recommendations in the FDA-approved drug label, may not be supported by scientific and clinical evidence, and may not be accurate,” the FDA said in a statement on Nov. 1.

23andMe’s pharmacogenetic test has been evaluated and authorized for marketing by the FDA.

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