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FDA Cracks Down on DNA Testing Products Marketed Directly to Consumers

Nov 26, 2013

The U.S. Food and Drug Administration (FDA), in a crackdown on genetic testing products currently marketed directly to consumers, has demanded that the company 23andMe immediately stop selling and marketing its DNA testing service until it receives FDA clearance.

The FDA sent CEO Anne Wojcicki a scathing warning letter, which was posted on the agency’s website on Monday, noting that 23andMe had failed to provide adequate evidence that its Personal Genome Service (PGS) provided accurate results, The New York Times reports. The FDA writes in the letter that it is “concerned about the public health consequences of inaccurate results from the PGS device.”

The company’s test, which costs $99 and is sold only through the company’s website, analyzes the DNA in a saliva sample. Among the things consumers learn is whether they might be at higher or lower risk of developing certain diseases.

Since such tests first became available to consumers, the companies have faced questions about whether the tests should require FDA approval. Also, does use of these products constitute the practice of medicine—and if it does, then should a physician’s involvement be required. 23andMe maintains that consumers are entitled to the information in their own DNA, though the company has been in talks with the FDA since 2009 about how its tests could receive regulatory approval, according to the Times.

The warning letter noted that 23andMe’s application for approval had lapsed because the company did not provide some additional information requested by the FDA. The agency expressed in the letter particular concern over a test for mutations that would indicate whether a woman has a very high risk of getting breast cancer. A false positive on such a test could lead to an unnecessary preventive mastectomy.

But Misha Angrist, an assistant professor at the Institute for Genome Sciences and Policy at Duke, said it was “borderline absurd” to think that someone would get a mastectomy based on results from a $99 test, without follow-up.

Scott R. Diehl, director of the center for pharmacogenomics at Rutgers, welcomed the FDA action. He said tests for breast cancer risk and drug side effects required guidance from doctors and genetic counselors, and that these products “really have no place” being offered directly to consumers.

The company has 15 business days to respond to the FDA’s warning letter.

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