FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice
This article was originally published in The Gray Sheet
The agency tells direct-to-consumer genetic testing company 23andMe in a strongly-worded warning letter that it should immediately stop marketing its Personal Genome Service until it can gain clearance. The firm says it will address the agency’s concerns.
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A day after 23andMe gained US FDA go-ahead for a DTC genetic test service to inform patients about their ability to metabolize medications, the agency issued a safety communication, paired with a joint statement from device- and drug-center heads, warning consumers against trusting genetic tests that have not been vetted by FDA.
New US FDA Commissioner Scott Gottlieb made only one direct mention of medical devices in his first speech to the agency, highlighting the promise of devices that empower consumers to be "better stewards of their own care." Gottlieb has been a strong proponent of FDA largely staying out of the oversight of many products in this category, in particular, DTC gene tests and digital-health tools.
23andMe has made it full circle with at least 10 direct-to-consumer genetic predisposition tests gaining FDA go-ahead for testing services to provide information on an individual's risk for developing Alzheimer's, Parkinson's, and celiac disease, among others. The de novo classification comes three-and-half years after the firm's DTC genetic testing service was forced off the market by FDA, and two years after it was able to relaunch carrier-screening test services.