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23andMe Gains FDA Market Authorization to Sell PGx Test Reports Directly to Consumers

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 23andMe authorization to sell tests for 33 pharmacogenetic variants directly to consumers.

The reports, the FDA said, provide consumers information about genetic variants that may be associated with their ability to metabolize some medications and help inform discussions with their healthcare providers.

The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests directly to consumers.

Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health within FDA's device division, said in a statement announcing the authorization that 23andMe's PGx test reports do not determine whether a drug is appropriate for a patient, they do not contain medical advice, and they should not be used to diagnose diseases.

"Consumers should not use this test to make treatment decisions on their own," Stenzel cautioned, adding that doctors also shouldn't base treatment decisions solely on 23andMe's test reports. "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."

23andMe's PGx test "does not describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug," the agency added.

Since 2013, when 23andMe stopped selling health-related reports following an FDA warning letter, the company has steadily worked to reintroduce tests it used to provide with the agency's blessing. The FDA has already granted 23andMe DTC marketing authorization for testing three BRCA1/2 variants, for its genetic health risk reports, and for carrier screening reports.

As with the PGx test reports, the FDA similarly warned consumers in authorizing 23andMe's limited BRCA test in March that they shouldn't make treatment decisions based on the results and that most BRCA1/2 mutations that are known to increase a person's risk for certain cancers aren't detected by 23andMe's test. When authorizing 23andMe's health risk reports last year, the agency cautioned that consumers should understand that genetics is one risk factor for developing a disease, and having a pathogenic mutation doesn't mean they'll definitely develop that disease.

The agency said it reviewed data from 23andMe that showed its tests could correctly detect PGx variants of interest in saliva samples, and that those results were reproducible. 23andMe also submitted data from user comprehension studies demonstrating that consumers could understand test instructions, what the reports mean, the test's limitations, and how to interpret the results.

The agency reviewed 23andMe's test through the de novo premarket review pathway for low-to-moderate risk devices. Similar to past authorizations of 23andMe's products, the agency established eight special controls, or criteria, that the company must meet in terms of test accuracy, performance, and labeling, before selling its PGx tests directly to consumers.

For example, the FDA stipulated a labeling requirement containing a warning statement that the consumer should not use the PGx test results to stop or change any medication. "These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test," the FDA said.