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.

As such, the FDA says that it has been in contact with 23andMe since 2009, seeking to have the tests brought under the appropriate regulations. Despite that effort, the FDA claims that 23andMe has expanded its list of intended uses and that the tests let buyers "take steps toward mitigating serious diseases."

The agency is apparently fed up with the delays. "More than five 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 [testing service]," the letter states. It also says that in January 2013, 23andMe claimed that it was doing further testing for its approval application, testing that would take several months to complete; nearly a year later, it never submitted the results of the testing.

As a result, the FDA has now ordered 23andMe to pull its test off the market. The company has 15 working days in which to respond to the FDA's letter with documentation of the corrective action that it has taken.

Know thyself

This isn't the first run-in between the FDA and personal genomics companies. Back in 2010, the agency sent a series of letters informing these companies that they were selling medical devices (here's a typical example); in response, all but 23andMe left the market.

Since then, the company has been doing a careful balancing act. Peter Schols, who founded the high-end medical testing company Gentle, told Ars, "23andMe has always been very ambiguous about their DNA test. On the one hand, they claim their test is 'for education and entertainment only and not for diagnostic use' on their website. On the other hand, they test for severe diseases like BRCA-related breast cancer, Alzheimer's, and Parkinson's without providing any counseling or advice." The letter seems to suggest that the FDA will no longer tolerate this balance; Schols called it "very relevant to the entire personal genomics industry."

More generally, the argument focuses on whether we have an unfettered right to information about our own bodies when that information is medically actionable. Many people view genetic information as the most personal information available, given that it's a central part of who we are. But the FDA believes some regulation is necessary and is already working to ensure the accuracy of other diagnostic tests (such as blood glucose levels) because the medical implications are so significant.