FDA to 23andMe: Stop Marketing Kits

The US Food and Drug Administration blocks the marketing of unapproved genetic tests.  

Nov 26, 2013
Kerry Grens

WIKIMEDIA, APERS0N23andMe, a California company at the forefront of personalized genetic testing and no stranger to controversy, is in hot water with the U.S. Food and Drug Administration (FDA). The agency put an end to the company’s marketing of its $99 Personal Genome Service (PGS) because the tests were not given regulatory clearance. “Hope you weren’t planning to give your relatives the gift of genetic insight through 23andMe this holiday season,” writes Kashmir Hill at Forbes.

The kits offer genetic information for consumers on 254 different diseases and conditions. In a warning letter to 23andMe CEO Anne Wojcicki, the FDA explains that the company submitted applications for some of these indications, but that “23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it.” The letter goes on to say that the agency has worked with the company since 2009 to help it comply with regulations, but “we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.”

The company has had little by way of response, although the San Francisco Chronicle posted a tweet from 23andMe co-founder Linda Avey, who said: “So much for patient empowerment,” and linked to the FDA’s warning letter.

According to the New York Times, about a half million people have used the service to date. The FDA’s biggest concern is that consumers might use it to self-manage any health risks that come to light as a result of the testing, and that a poor understanding of the results or inaccurate testing could lead to people inappropriately taking drastic measures. Timothy Lee at the Washington Post disagrees with the move. “Patients have a right to make dumb decisions if they want to,” he writes. “We don’t ban patients from reading medical textbooks or WebMD, even though doing so undoubtedly leads to some harmful self-diagnoses.”

Christine Gorman at Scientific American’s Observations blog backs the FDA, however. “Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results,” she writes, something that is “still quite difficult and expensive in most cases.”

The FDA gave 23andMe 15 days to respond with a description of how it’s addressing the agency’s concerns.