The FDA has ordered 23andMe.com to halt sales of its DNA analysis product, claiming that it's currently being marketed "without marketing clearance or approval" from regulators. By studying a sample of a user's saliva, the company alerts customers about any diseases they currently carry or are at risk for. (23andMe says it can identify up to 254 diseases and other medical conditions.) The company has twice submitted its test kit for review as a medical device, but the FDA says it has largely failed to satisfy “the issues described during previous interactions” between both sides.
Specifically, the FDA highlights "the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these." As one example, the FDA points out that a false positive for breast or ovarian cancer could "lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions." On the opposite end, a false negative could "result in a failure to recognize an actual risk that may exist."
"Serious concerns are raised if test results are not adequately understood by patients..."
The idea of patients self managing any conditions they may have without a doctor's input seems to be a major concern for the FDA. "The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported." Doctors associations have echoed these complaints in recent years, fearing that patients aren't able to properly interpret all that these saliva kits tell them. Direct-to-consumer genetic tests have already been banned in New York and Maryland as a result.
The FDA says it has worked tirelessly with 23andMe (over a number of years) to resolve the situation: it's reportedly engaged in "14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" with the company. But those discussions have apparently proven unsuccessful, and in the meantime, 23andMe has risen in popularity and ramped up marketing for DNA analysis — even airing ads on television for the first time. Now the company faces a major obstacle: it must satisfy the FDA's requirements or face punishments including injunction, product seizures, or major fines.
Update: In a statement provided to The Verge, 23andMe has responded to today's FDA demands. "We have received the warning letter from the Food and Drug Administration," the company says. "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."
Update (9:40pm ET, November 26th): 23andMe co-founder Anne Wojcicki has written a blog post addressing the matter. "We stand behind the data that we return to customers," says Wojcicki, "but we recognize that the FDA needs to be convinced of the quality of our data as well." Wojcicki reiterates that 23andMe has been "behind schedule with [its] responses" to the FDA, but says that she is "committed to making sure that 23andMe is a trusted consumer product."