23andMe, the brainchild of Google co-founder Sergey Brin’s estranged wife, Anne Wojcicki, has received a lot of press for its surprisingly accessible genetic mapping service, but the latest headlines aren’t in praise of the mail-order spit test. In fact, the FDA has demanded that the company cease marketing of its $99 kit, citing the risk of false results that could lead consumers to undergo unnecessary health procedures.
In a stern letter issued on Monday, the company, whose stated mission is “to be the world’s trusted source of personal genetic information,” was told to “immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
The company’s saliva-based test identifies 240 genetic traits and can provide information such as if biological children are at risk for inherited health conditions, personal genetic health risks and likely drug responses. But the warning given to the Google- and Johnson & Johnson-backed company is just the latest as a heated debate continues over direct-to-consumer genetic testing and claims made by 23andMe.[more]
In the letter to 23andMe CEO Wojcicki, who co-founded the firm in 2006, the FDA said it could take more serious action, including product seizures, if the company does not respond within 15 days and begin corrective steps. 23andMe posted the following statement on Facebook:
“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.”
Reactions from consumers was mixed, ranging from: “Pathetic, the FDA has no right to tell me what I can learn about my own genetic information,” to, “Actually, the FDA’s concerns are quite reasonable. If you’re going to claim these medical benefits, if people are going to take the results to doctors, if we’re going to rely on them for medical action, they should be licensed for accuracy just like an x-ray machine or anything else.”
The FDA has had “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications,” since 2009 with 23andMe, according to NPR. The final straw was apparently 23andMe’s first national TV ad campaign that aired in August.
“The FDA and the company have done a sort of strange frenemy dance since the beginning,” geneticist Misha Angrist told The Verge, noting that 23andMe has been in business for six years without “marketing approval” and consistently lax in response to regulators.
Lauren Fifield, health policy expert at Practice Fusion which works with the FDA, told VentureBeat, “My gut tells me that the company isn’t challenging process but is instead challenging the very regulatory definition of what it is to be a device. What remains to be seen is whether the company and tech industry can convince the government that safety can be increased, or at least balanced, by innovation rather than set at odds.”
And even if they remain at odds, “the cow is a fair ways out of the barn,” added Angrist. “Ultimately, I don’t think the FDA can keep people from learning about the content of their own cells. It’s simply gotten too cheap and too easy to do.”