FDA approves 23andMe’s direct-to-consumer DNA test assessing patient’s ability to respond to antidepressants

The U.S. Food and Drug Administration (FDA) announced [October 31] that it has approved the marketing of 23andMe’s reports on pharmacogenetics, which the genetic-testing company claims are designed to assess whether genetics may affect an individual’s ability to metabolize certain drugs including antidepressants.

The company is characterizing the move as the “first authorization of a direct-to-consumer report on pharmacogenetics.” But with the approval of 23andMe’s Personal Genome Service test also come a number of caveats, the most glaring of which being that the test is meant to facilitate conversations with healthcare professionals rather than inform any kind of final word on medications or treatments.

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The FDA says the tests aren’t meant to be used to inform the recommendations for treatment by a provider, assess a patient’s ability to respond to medications, or even be interpreted without additional “independent pharmacogenetic testing.”

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“Even if you test negative for all known [disease] genes, your risk for that disease may still be increased based on your family history,” Mary Freivogel, president of the National Society of Genetic Counselors, told Stat [in 2017]. “A negative 23andMe test might provide false assurance.”

As appears to be the indication from the FDA, it may be best to take any genetic-testing kit with a grain of salt.

Read full, original post: FDA Approves New 23andMe Pharmacogenetic Reports, But There Are Some Caveats