The U.S. Food and Drug Administration has ordered 23andMe, the genomic startup co-founded by Anne Wojcicki, Linda Avey and Paul Cusenza in 2006, to stop selling its at-home DNA testing kits as of November 22. As Bloomberg reports, a letter from the FDA sent to the company made public today classifies the kit as a medical device and outlines that it required regulatory approval before being sold.
Part of 23andMe’s mission is to help people assess their risk and the risk of their offspring for genetic, inheritable diseases and conditions, and that’s what the FDA has apparently taken issue with. Determining medical risk classifies the kit as a medical device, the organization says, even if that’s not the sole use 23andMe’s service (many get tested simply out of curiosity, or to help support ongoing research initiatives). 23andMe’s database of 400,000 total individuals is a veritable treasure trove of info for genetic researchers. Still, if a patient receives a prognosis that indicates they’re likely to develop breast cancer, and gets a double mastectomy as a preventative measure, only to have that turn out to be a false positive, that’s a big risk and justified cause for scrutiny.
23andMe has investment from Google, which first contributed to a $3.9 million into the company in a Series A round in 2007, and most recently the company raised $50 million in a Series D round that included Google, NEA, Milner and more. The self-testing service, which simply requires a customer to provide a saliva sample via mail, also won TIME magazine’s “Invention of the Year” award back in 2008. The startup has faced regulatory hurdles before, including from New York and California state organizations attempting to block the tests on licensing grounds, but 23andMe later secured licensing to continue to operate.
23andMe has previously submitted applications to the FDA in an attempt to get their devices approved, but the FDA said those failed to address issues that have come up before between it and the company. There’s also the spectre of vested interests looming over this case, however: The biggest U.S. health insurer in operation raised a stink about 23andMe’s tests back in 2012. 23andMe has identified a massive, lucrative market opportunity and there’s good reason for insurers and others to want a say in how the money shakes out.
We’ve reached out to 23andMe for comment, and will update this story should they provide more information.
Update – 23andMe provided the following statement:
We have received the warning letter from the Food and Drug Administration. 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.
Photo courtesy flickr user lovemypit.