23andMe is no longer just for ancestry testing. An FDA green light has placed the company's first at-home drug metabolism test among its pantheon of health-focused genomic offerings.
The test searches for 33 variants of eight genes from a saliva sample to determine how a person breaks down and transforms more than 50 commonly prescribed and over-the-counter medications—all potentially altering their effectiveness. This includes the genes that code for the CYP2D6 liver enzyme, which plays a role in the metabolism of certain opioid painkillers and other drugs.
Its de novo clearance last October, however, was granted with special controls and labeling requirements: The results of the direct-to-consumer test should be confirmed with further clinical pharmacogenetic analysis before any healthcare provider makes a medical decision, the agency said. In addition, the test’s reports do not describe how a user would respond to any specific drug.
“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,” the FDA’s Tim Stenzel, M.D., Ph.D., director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said in a statement at the time.
Still, it clears a wide path for others, as DNA testing continues to become cheaper and cheaper—and gives patients genetic information that they can bring into discussions with their physicians as they decide on the course of their care.
Before this, 23andMe had collected three separate de novo authorizations from the FDA—including for direct genetic tests for carrier status, covering conditions such as Parkinson’s disease, late-onset Alzheimer’s and Gaucher disease—as well as health risk reports and select BRCA1 and BRCA2 variants.
For each, including the pharmacogenetic test, 23andMe was required to submit studies that not only showed the tests were scientifically valid and reliable, but that the results were understandable to at least 90% of consumers—and above that, that they understood not to use the reports to make any changes to their treatment regimen without consulting a doctor.