NIIH Last Friday, the Food and Drug Administration sent a letter to the most popular personal genomics service, 23andMe, ordering the company to stop selling its genetic testing kits.

According to the FDA’s letter, the company has been advertising that its tests offer diagnostic information for a variety of human conditions, placing them in the category of a “medical device” and thus within the agency’s jurisdiction.

Accordingly, the FDA has been working with the company since 2009 to get 23andMe’s testing approved.

Now, the FDA has apparently run out of patience. What counts as a “medical device”? A quick trip to the “benefits” section of 23andMe’s website shows that the company promotes its tests as diagnostic for genetic diseases and says that they provide an indication of risk for complex conditions like diabetes and Alzheimer’s. In addition, the page suggests that the company’s testing can provide warnings of potential interactions between genes and drugs, such as cholesterol-lowering statins and blood thinners.

According to the FDA, this makes a 23andMe test a “medical device” under Section H of the Federal Food, Drug, and Cosmetic Act. In practical terms, the agency warns that people may attempt to self-medicate based on the combination of the results they receive and the information on 23andMe’s website.

The agency’s letter also cites the dangers that could be posed by a false-positive result for tests such as those involving genes associated with breast cancer.     

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