Just three months after airing its first DTC campaign, the Google-backed genetics firm 23andMe received a warning letter from FDA saying it must discontinue marketing of its Personal Genome Service (PGS).

Concerns centered on the device’s growing list of medical uses on the company website. Some of those uses, FDA said, have “not been classified and thus require premarket approval.” The agency said marketing must be discontinued until the device has been properly tested.

In the letter, regulators said some of those intended uses, like “assessment for BRCA-related genetic risk and drug responses,” were “particularly concerning,” due to the chance of false-negatives and false-positives, which could lead to unnecessary treatment or a missed diagnosis. 

PGS, as described on 23andMe’s website, uses customers’ DNA to provide “specific health recommendations” and “learn about and explore their DNA.”

In an e-mailed statement to MM&M, 23andMe confirmed receipt of the directive.

“We have received the warning letter from the Food and Drug Administration,” the firm noted, adding, “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are fully committed to fully engaging with them to address their concerns.”

The agency said 23andMe “initiated new marketing campaigns, including television commercials that, together with an increased list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining proper marketing authorization from FDA.” 

23andMe submitted a 510(k) medical device clearance for PGS in 2012, but “failed to address issues described during previous interactions for use,” said Alberto Gutierrez, Director of FDA’s Center for Devices and Radiological Health.