The FDA ordered 23andMe to stop selling its Saliva Collection Kit and Personal Genome Service (PGS), accusing the genetic test developer of violating the Federal Food, Drug, and Cosmetic (FD&C) Act of marketing the test without first obtaining clearance or approval from the agency.

In a warning letter to 23andMe, the FDA’s Center for Devices and Radiological Health (CDRH) said it considered PGS as being “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.” CDRH cited intended uses for PGS listed on 23andMe’s website during a November 6 visit, which it said included providing “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. Most of these uses have not been classified and thus require premarket approval or de novo classification, as the FDA has explained to you on numerous occasions,” according to the warning letter, written to 23andMe CEO Ann Wojcicki by Alberto Gutierrez, director of CDRH’s Office of In vitro Diagnostics and Radiological Health.

The company’s website this morning promoted the $99 “Spit Kit” which “reports on 240+ health conditions and traits: “Based on your DNA, we’ll provide specific health recommendations for you. Because everyone’s results are different, the recommendations will vary,” the website states, before presenting several “example recommendations” users may receive with their reports.

In one example, a “Health Risk Report” states: “Your DNA puts you at higher risk for a condition called celiac disease.” After describing the disease, the example concludes: “Talk to your doctor about testing for gluten sensitivity.”

The FDA warning letter called “particularly concerning” some of the PGS kit’s uses—including assessments for BRCA-related genetic risk and drug responses such as warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity—because of the potential health consequences that could arise if personal genome diagnostics were to give false-positive or false-negative assessments for such indications.

“The FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with the FDA’s regulatory requirements is to ensure that the tests work,” Gonzalez wrote.

According to the letter, the FDA has interacted with 23andMe since 2009 evaluating whether the PGS device qualified as a “Class II” device requiring only 510(k) clearance or de novo classification, rather than premarket approval (PMA). Those interactions, the agency stated, included more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications. 23andMe submitted two 510(k) applications for PGS in July and September of 2012—applications the FDA now considers withdrawn.

“We provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk-mitigation strategies,” Gonzalez wrote. “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.”

CDRH faulted 23andMe for not having completed some studies, and not starting other ones, needed for a marketing submission for the PGS, despite a January 9 letter stating the firm was completing “additional analytical and clinical validations” for tests submitted earlier, and also “planning extensive labeling studies that will take several months to complete.” 

At deadline 23andMe had yet to respond to the FDA’s warning letter, dated November 22.

No mention of the letter has yet appeared on 23andMe’s blog, where on October 1 the company justified its pursuit of U.S. Patent No. 8,543,339, awarded to the company September 24 for “gamete donor selection based on genetic calculations.” The technology is designed to support its Family Traits Inheritance Calculator, an online tool launched in 2009 to offer users what the company calls “an engaging way for you and your partner to see what kind of traits your child might inherit from you.” However, some groups criticized the company for pursuing the patent, raising ethical issues, saying such tools could lead to “designer” babies with individual traits prechosen by users.

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