Direct-to-consumer genomics company 23andMe sells $99 DNA tests that provide information ranging from ancestry
to diabetes risk and drug responses
using just your saliva. They’ve always maintained that the analyses provide general information—and not medical services.
That is, until last year, when the company reversed their stance, Nature reports
, submitting paperwork to the U.S. Food and Drug Administration for clearance on its genetic tests.
Now the FDA has ordered the company to stop marketing their Personal Genome Service (PGS) to consumers, saying 23andMe hasn’t provided any studies that validate the accuracy of the tests, which require approval under the Federal Food, Drug and Cosmetic Act, Science explains
In a warning letter to 23andMe
last week, the FDA expressed concerns “about the public health consequences of inaccurate results from the PGS device,” which has not been approved for use as a medical device. For instance:
If the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery... while a false negative could result in a failure to recognize an actual risk that may exist.
[Even after] more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications... we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.
The agency, which says that 23andMe had stopped communicating since May, has given the company 15 days to take corrective action.
23andMe released a statement
on Monday, saying they will work on addressing the FDA's concerns. And in an update
yesterday, the company writes: "We stand behind the data that we return to customers—but we recognize that the FDA needs to be convinced of the quality of our data as well." And:
This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future.
But the warning might be a blow to the direct-to-consumer market, which is already struggling. Since 2010, a dozen such firms have received letters from the FDA suggesting their tests be regulated as medical devices, Nature reports
; almost all of these companies have since folded or changed their business models.