The U.S. Food and Drug Administration has asked the maker of a popular DNA-testing mobile device to "immediately discontinue marketing" the device until its claims can be verified as accurate.
23andMe, which seeks to be the "world's trusted source of personal genetic information" thanks to its $99 DNA tests, has been slapped with a warning from the FDA that it's in violation of the Federal Food, Drug and Cosmetic Act.
The company – whose founder, Anne Wojcicki, is married to (but separated from) Google co-founder Sergei Brin – markets its Personal Genome Service as a way for consumers to trace their lineage. It can reportedly offer an estimate of someone's "genome-wide percentage of Neanderthal ancestry" and also to help clue them into their particular genetic predisposition to diseases such as cancer and Parkinson's.
It's in that capacity that the product has run afoul of the FDA, according to the agency's letter, which was sent to Wojcicki on November 22. Regulators have told 23andMe that it must prove its tests are accurate and receive FDA clearance.
"This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body," said the letter, written by Alberto Gutierrez, director of the Office of In vitro Diagnostics and Radiological Health.
The letter cites the 23andMe website, which touts the PGS as a way to offer "'health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks" and "drug response," and specifically as a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease and breast cancer.
"Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act," Gutierrez stated in the letter. "Most of these uses have not been classified and thus require pre-market approval or de novo classification, as FDA has explained to you on numerous occasions."
According to Bloomberg News, 23andMe "submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews."
"Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions," Gutierrez wrote.
The controversy comes at a time where consumers are paying more attention than ever to their health information – including their genetic profiles. Still, there's confusion about what it all might mean.
A survey commissioned by 23andMe this past April showed that while just 2 percent of respondents said they'd had a genetic test done, 73 percent said they'd be interested in getting one.
"A majority of Americans is interested in the knowledge that their genetic information can provide," said Joanna Mountain, senior director of research for 23andMe, in a statement after the poll was published. "However, many are unfamiliar with the basics of genetic inheritance and unaware of what they might learn about themselves, in terms of health or ancestry, from their DNA."
It also dovetails with the burgeoning patient engagement movement, with more and more people demanding access to their personal data.
On 23andMe's Facebook page, some customers are angry about what they see as the government's intrusion on their personal health information.
"The FDA has no right to tell me what I can learn about my own genetic information," wrote one.
But another poster suggested the issue isn't so cut-and-dried: "They have every right to tell you what can be inferred from said data."
"I don't think so," wrote another. "The information about my DNA is not their property, it is mine and whoever I give authorization to have it."
But a fourth Facebook user explained what's an issue.
"Actually, the FDA's concerns are quite reasonable," he wrote. "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."
Indeed, wrote Gutierrez in the FDA's warning letter, that's exactly the risk: Patients might be spurred to take drastic medical action based on genetic information from the DNA kits that could be inaccurate.
The "potential health consequences that could result from false positive or false negative assessments for high-risk indications" are too great, he wrote.
Specifically, he pointed to "risk assessment for breast or ovarian cancer reports" based on the BRCA caretaker gene. A false positive, Gutierrez wrote, "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."
On its Facebook page, 23andMe posted a statement for the media: "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."
The company has less than two weeks to respond to the FDA's concerns. Failure to "take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice," wrote Gutierrez.
