FDA grants 23andMe’s consumer genetic variant test De Novo approval, with some caveats

While the test offers information on whether or not certain treatments may be effective, the regulatory agency stressed that the results should never be used in care decisions.
By Dave Muoio
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Yesterday afternoon the FDA announced that it would permit 23andMe to market its Personal Genome Service Pharmacogenetic Reports test. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications.

The purpose of this test is to inform patients and encourage them to more thoroughly discuss treatments options with a health care provider. However, the agency stressed that these are not to be the sole genetic testing results considered by the patient or the provider when weighing treatment options, and that any decisions should instead be based on independent pharmacokinetic clinical testing.

To reflect this stipulation, FDA granted the De Novo authorization with eight “special controls,” included among which is a labeling requirement warning the consumer not to use the test results for any medication decisions.

“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers. We know that consumers are increasingly interested in genetic information to help make decisions about their health care,” 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 statement.

“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. 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 health care provider and results have been confirmed using clinical pharmacogenetic testing.”

In a statement, the FDA said that its review of the test found adequate evidence of its accuracy and reproducibility. In addition, 23andMe also submitted data from studies gauging users’ comprehension of the test’s results and limitation.

Why it matters

Regulation of direct-to-consumer genetic testing has been something of a fuzzy space for a number of years due to concerns over privacy, accuracy and actionability.

Today’s De Novo approval and its accompanying caveats offer a new view on how the regulatory agency is looking to handle these tests, especially in regard to debates over what role the average consumers should take in their care decisions.

Even though the clearance at hand warns against using the test alone to make medication determinations, it's a significant step forward on the road from ancestry and wellness-focused consumer genomics to personalized medicine.

What’s the trend

23andMe, arguably the leader of this market, offered its health tests in the US until receiving a very public rebuke from the agency and halting sales for two years. While the company and others were forced pursue individual approvals for each and every health test offered, the FDA unveiled a special pathway for direct-to-consumer genetic health risk tests last year that would allow companies to bypass premarket certification for individual tests after submitting to a one-time review of their process.