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FDA Tells 23andMe to Halt Marketing Personal Genome Service

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has told 23andMe that it must stop marketing its spit test and genome service to consumers because it has failed to address FDA's questions about the clinical and analytical validity of the product.

In a letter sent to company CEO Anne Wojcicki on Friday, the FDA said 23andMe must cease marketing the Saliva Collection Kit and Personal Genome Service to consumers immediately, and may not start marketing it again until it has received the agency's authorization.

Although 23andMe filed for FDA 510(k) clearance in 2012 for several of the intended uses for its genome service, the FDA said the company has failed to respond to questions the agency has about the validity of those uses.

In the letter, FDA Office of In vitro Diagnostics and Radiological Health (OIR) Director Alberto Gutierrez stated that the product is a medical device because it is "intended for use in the diagnosis of diseases 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."

For example, the 23andMe website markets the PGS for providing health reports on 254 diseases and conditions, including categories for health risks, carrier status, drug response, and "steps toward mitigating serious diseases," Guitierrez said. He noted that the company's list of intended uses "has grown over time," even though many of these require premarket approval or de novo classification.

During the summer the Mountain View, Calif.-based consumer genetics testing firm also began a television marketing campaign, though it is not aimed at the detection of specific diseases or ailments, but, instead, "focuses on educating consumers about how understanding their DNA can help them make more informed and proactive health decisions," according to 23andMe's statement at the time it launched the campaign.

In a statement today, 23andMe responded, "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.”

Gutierrez said his office is particularly concerned about assessments for BRCA-related genetic risk and drug responses, such as warfarin sensitivity, clopidogrel response, and others, because false positive or false negative assessments in these areas could lead to health consequences.

Gutierrez added that although OIR responded to 23andMe's 2012 510(k) application with questions about these concerns, the company has not provided adequate answers yet, even though his office has provided "ample feedback" about the kinds of data it will require to review the PGS.

He said the FDA has already "spent significant time evaluating the intended uses of the PGS" to decide whether or not it could be classified as a class II device, which would require only the 510(k) clearance or de novo classification, or whether it would require premarket approval.

The OID director also said the FDA has proposed modifications to the PGS labeling that could mitigate any risks and render its intended uses appropriate for de novo classification.

"However, 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 stated

Although the company told the FDA early this year that it is completing additional analytical and clinical validations and is planning "extensive labeling studies" that would take months to complete, Gutierrez said his office still has not received the information it is seeking.

"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS," Gutierrez wrote.

Not only has the company failed to provide updates on these studies, or to adequately answer the FDA's questions, it also has expanded the marketing of its PGS and its list of indications.

That the company has taken those steps, Gutierrez wrote, show "that you plan to expand the PGS's uses and consumer base without obtaining authorization from FDA."

Last week’s letter to 23andMe is just the most recent action from the FDA, which has had an uneasy relationship with direct-to-consumer genetic testing firms. In 2010 the agency sent letters to several such companies, including 23andMe, saying the FDA believed it sold unapproved diagnostic devices.

Congress also investigated such firms the same year.

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