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Frustrated U.S. FDA Issues Warning to 23andMe

The U.S. Food and Drug Administration (FDA) is cracking down on DNA testing company 23andMe for the marketing of its Personal Genome Service (PGS). In a 22 November warning letter addressed to CEO Anne Wojcicki, FDA demanded that the Mountain View, California-based company stop selling its $99 testing kit, which uses a sample of a buyer’s saliva to identify genetic variants linked to more than 240 “health conditions and traits,” until it receives FDA authorization.

The service claims to identify risks, predict drug response, and inform treatment decisions—uses which require approval under the Federal Food, Drug, and Cosmetic Act, FDA holds.

The agency followed up with an announcement in the Federal Register today, announcing that it is issuing "guidance" to companies that produce in vitro diagnostic products labeled “for research use only” and “for investigational use only.” The moves may signify a new push for regulatory control over the field of direct-to-consumer genomics. (On its website, 23andMe says its services are “for research, informational, and educational use only. We do not provide medical advice.”) 

The accuracy of 23andMe’s DNA tests is central to FDA’s concerns. A false positive result could lead consumers to seek unnecessary and possibly harmful screening or treatment, regulators worry, while a false negative could allow a major risk to go unnoticed. FDA found tests predicting a person’s sensitivity to certain drugs, including the anticoagulant warfarin, to be “particularly concerning,” saying that people may change their dosage or discontinue a drug without professional advice. The letter scolds 23andMe for failing to provide evidence to FDA that its tests work: “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.”

23andMe acknowledged FDA’s letter but has remained silent on whether it plans to continue selling its PGS. “We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission,” the company said in a statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

23andMe has been on a long road to FDA approval. It submitted documentation to FDA for some of the test’s uses in 2012. “We remain strong in our belief that consumers have a fundamental right to their personal genetic data,” the company wrote in a 2012 blog post announcing the submission. “But we also recognize that appropriate oversight of this industry can be a stepping stone on the path to realizing that revolution.”

According to FDA’s letter, this oversight process stalled when 23andMe failed to address questions and provide additional information that the agency requested. The agency says it now considers the company’s applications withdrawn, suggesting it will have to start over.

The move may anger advocates of direct-to-consumer genomics, but it likely won’t surprise them. “It’s been a long time coming,” says Jennifer Wagner, an attorney and research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies in Philadelphia. “FDA has been signaling for some time that it wanted to regulate personal genomics.” But she suspects that 23andMe got “caught in the crosshairs,” thanks in part to a recent advertising push, which includes testimonials about life-changing diagnoses.

Wagner predicts that the company may have to rein in its marketing, or add language telling consumers to seek confirmation of test results with their doctors, while it conducts the validation studies that FDA demands. She says other direct-to-consumer companies—even those that have long questioned FDA’s authority in regulating personal genomics—will have their eyes on 23andMe to “see how they’re navigating this uncertain world.”

*Update, 25 November, 7:30 p.m.: This article was updated to clarify that FDA has issued guidance to companies that produce in vitro diagnostic products labeled “for research use only” and “for investigational use only," not an announcement of proposed regulation.

*Correction, 2 December, 4:10 p.m.: The CEO of 23andMe is Anne Wojcicki, not Ann Wojcicki. The spelling of her first name has been corrected.