F.D.A. Demands a Halt to a DNA Test Kit’s Marketing

Peter DaSilva for The New York Times

The personal genome testing company 23andMe is backed by Google and run by Anne Wojcicki, wife of the Google co-founder Sergey Brin.

In a crackdown on genetic testing offered directly to consumers, the Food and Drug Administration is demanding that 23andMe immediately cease marketing its main DNA service until it receives marketing clearance from the agency.

In a warning letter issued Friday and posted on the F.D.A.'s website Monday, the F.D.A. said that the company had failed to provide adequate evidence that its Personal Genome Service provided accurate results.

“F.D.A. is concerned about the public health consequences of inaccurate results from the P.G.S. device,” the agency said in its letter. “The main purpose of compliance with F.D.A.'s regulatory requirements is to ensure the tests work.”

23andMe, which is backed by Google and run by Anne Wojcicki, wife of the Google co-founder Sergey Brin, is perhaps the best known of the personal genome testing companies. Its service, which has been used by about half a million people, tells consumers whether they might be at a higher or lower risk of developing various diseases, among other things.

Whether such tests require F.D.A. approval and whether doctors must be involved in ordering such tests have been the subject of debate. 23andMe has long held that consumers are entitled to the information on their own DNA, though it has also been talking to the F.D.A. about how its tests could receive regulatory approval.

Ms. Wojcicki did not immediately respond to an email seeking comment and her company, which is based in Mountain View, Calif., had not yet responded on its website Monday morning.

The F.D.A. warning letter said the agency considered the Personal Genome Service a medical device that required approval.

The letter noted that 23andMe did apply for approval for some uses of the test in 2012. However, it said, the company did not provide the additional information requested by the agency, so the agency considered the applications to have been withdrawn.

The letter accused 23andMe of dragging its feet despite “14 face-to-face or teleconference meetings, hundreds of email exchanges and dozens of written communications” since 2009.

“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the P.G.S. for its intended uses, which have expanded from the uses that the firm identified in its submissions.”

The letter added, “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 P.G.S.'s uses and consumer base without obtaining marketing authorization from F.D.A.”

What seems to have raised the most concern from the agency is 23andMe’s expansion into offering tests for mutations of genes that indicate a woman might have an extraordinarily high risk of getting breast or ovarian cancer. The F.D.A. said a false positive on that test could cause a woman to undergo a needless mastectomy.

The agency also seemed concerned about 23andMe’s expansion into testing of genetic variants to help predict people’s responses to drugs such as warfarin, a blood-thinning medication.

23andMe now sells its service, which also offers ancestry information, for $99. It is aiming to grow to 1 million customers by early next year. Part of its business plan is to use the information on its customers to perform biomedical research, such as finding genetic causes of diseases.

The F.D.A. first sent letters to 23andMe and some of its competitors in 2010, saying that regulatory approval would be required for the tests. Following that, some of the other companies stopped offering tests directly to consumers.

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