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The company’s Personal Genome Service Pharmacogenetic Reports test analyzes 33 variants of several genes.
23andMe can market a direct-to-consumer test that analyzes genetic variants and their association to medication metabolism.
The U.S. Food and Drug Administration today authorized the marketing of a 23andMe direct-to-consumer test that reveals whether a patient’s genetic variants are associated with their capacity to metabolize certain medications. The test is the first of its kind to secure FDA approval.
Regulators said 23andMe’s Personal Genome Service Pharmacogenetic Reports test, which can identify 33 variants for multiple genes, will empower patients to start educated discussions with their healthcare providers. But the agency was clear in saying that the assessment isn’t capable of concluding whether a patient should receive or avoid a certain medication.
“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,” Tim Stenzel, head of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “We know that consumers are increasingly interested in genetic information to help make decisions about their healthcare.”
The pharmacogenetic test comprises a patient-collected saliva sample, which is then sent to 23andMe for DNA analysis. Patients later receive a report detailing any genetic variants that could be linked to medication metabolism.
In judging the test, the FDA determined that 23andMe data proved the accuracy of the assessment and its ability to deliver reproducible results. Regulators also confirmed that patients understood the instructions and resultant reports, along with the test’s limitations and how to interpret the data.
The FDA also established eight special controls, including a warning label to discourage patients from stopping or changing medication consumption due to the test results. Agency officials said the controls “provide reasonable assurance of safety and effectiveness for this test.”
Echoing the concerns of some healthcare insiders, the FDA underscored several times that the test should be used only to spark discussion, noting that it does not offer medical advice or diagnoses.
“Consumers should not use this test to make treatment decision on their own,” Stenzel said. “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.”
Still, the approval is a major win for 23andMe, the biggest name in direct-to-consumer genetic testing.
The company — and its competitors — spent years in limbo, unable to market its tests for disease risk after an FDA ban in 2013. But 23andMe gained FDA approval for a genetic risk test in spring 2017, foreshadowing a genetic test for mutations in breast cancer genes that was authorized earlier this year.
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