UPDATED: FDA wants 23andMe's test off the market, citing risk to patients

Direct-to-consumer DNA testing outfit 23andMe has run afoul of the FDA, and the agency served up a warning letter demanding that the company take its genetic screens off the market until it gets the proper clearance.

23andMe invites customers to ship their saliva to its CLIA-certified labs, where it sequences samples and churns out information on gene mutations, health risks and drug responses through its Personal Genome Service (PGS). However, the company has never submitted adequate data to support its claims, the FDA said, and 23andMe has been selling the unapproved, unverified service for 5 years despite 14 meetings and hundreds of emails with agency staff. Now, in a warning letter dated Nov. 22, the FDA wants 23andMe to pull its products and get in line for FDA approval like all other medical device developers.

"Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses," the FDA wrote, and they "have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions."

23andMe purports that its product serves as a "first step in prevention" of many diseases, language that seriously alarmed the FDA. Among the company's screening targets are the cancer-tied BRCA1 and BRCA2 mutations, and the agency worries that 23andMe's unverified test could result in false positives that spur unnecessary patient surgeries or false negatives that delay needed treatment. Same goes for the test's promises of drug-response screenings, results of which could inspire patients to self-manage treatment and put themselves at risk.

"FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work," the agency wrote.

But the bigger problem, according to the FDA, is that 23andMe is well aware of its concerns. Since 2009, the agency has repeatedly advised the company on the necessary study protocols and validation measures it would need to get its product approved for marketing, the agency said, and in 2012, 23andMe got the ball rolling on a 510(k) clearance application. However, after some initial back and forth between the two parties, the line has gone dead, the FDA wrote.

"You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May," the agency wrote. "Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA."

23andMe said in a statement that it has received the warning and recognizes 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."

On its website, the company acknowledges that its test hasn't been cleared or approved by the FDA and says the information it provides "is intended for research and educational purposes only and is not for diagnostic use."

- read the warning letter