FDA Warns DNA Testing 23andMe to Halt Operation

The Food and Drug Administration has told 23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, to halt marketing of its over-the-counter genetic test, claiming it's being sold illegally to diagnose diseases, and with no proof it actually works.

The Saliva Collection Kit and Personal Genome Service, or PGS, is supposed to tell users whether they carry a disease, are at risk of a disease and would respond to a drug. In a public letter dated November 22, the FDA instructed personal genome startup 23andMe to immediately stop selling its testing service, as first reported by Regulatory Focus.

"[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS [personal genome service]," Alberto Gutierrez, director of in vitro diagnostics and radiological health wrote in the letter, adding that FDA interactions with 23andMe had included "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications."

"It is now nine months later, and you have yet to provide FDA with any new information about these tests," he wrote. "You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA. Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."

The FDA details just how hard staffers have tried to work with the company to sort out these issues, including more than 14 face-to-face meetings and teleconferences and "hundreds of email exchanges" in which the agency gave the company detailed instruction on what to do.

"We have received the warning letter from the Food and Drug Administration," the company told MobiHealthNews in an emailed statement. "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 committed to fully engaging with them to address their concerns."