FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice

16 Dec 2013

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.

Providing health reports on an individual’s specific diseases and conditions, carrier status, health risks and drug responses are medical device uses, requiring either premarket approval or 510(k) clearance, FDA told the Personal Genome Service testing provider 23andMe Inc. in a November 22 warning letter.

“We have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list...