FDA clears the first consumer genetic test for how well your medications may work — with caveats

SAN FRANCISCO — The Food and Drug Administration on Wednesday cleared the first DNA test meant to be marketed directly to consumers to help them determine how well certain drugs may work for them.

The test was developed by 23andMe and, as with other tests from the consumer genetics giant, customers will be able to simply mail in a spit sample to get results.

23andMe’s new test will provide information on 33 genetic variants that the company says are associated with how patients respond to more than 50 commonly prescribed prescription and over-the-counter drugs. Among them: the blood thinner known as clopidogrel, which is prescribed to prevent heart attacks and strokes.

The FDA’s marketing authorization came with crucial caveats. The agency cautioned that the test cannot assess whether a drug is appropriate, or gauge a patient’s ability to respond to any specific medication. The FDA also said that patients should not look to the test for medical advice or to make treatment decisions on their own; instead, they should only use the information to guide discussions with their health care provider.

23andMe said in a press release that it has not determined when the new test will become available. The release did not say how much the test will cost.

When it does hit the market, the new product will bring a new dynamic to a crowded commercial landscape of other so-called pharmacogenetic tests. Some of them are meant to be ordered by a health care provider or offered by a pharmacist: Just last month, Color Genomics became the latest genetic testing company to launch a physician-ordered test, as part of a $249 product, that reports on the potential effectiveness of antidepressants including Zoloft, Paxil, and Lexapro.

The genetic variants that 23andMe’s test will analyze include several that have been associated with how well the body processes medications for mental health.

But psychiatrists have pushed back on the commercial rush to use pharmacogenetics in their field, saying the application lacks supporting evidence and may not be worth the money.

23andMe had previously offered a pharmacogenetics test to U.S. consumers but, after running afoul of the FDA, pulled it back along with several other health-related tests. Earlier this year, the Silicon Valley company won FDA approval for the first direct-to-consumer test for the BRCA genes, which increase the risk of breast and ovarian cancer.

Speaking at a digital health conference in San Francisco earlier this month, 23andMe CEO Anne Wojcicki pointed to the pharmacogenetics test as something the company wanted to relaunch. “When we can bring pharmacogenomics back, then we have a complete product back,” Wojcicki said.