FDA Warns, Shames 23andMe Over Its Genetic Testing Kits

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The Food and Drug Administration has issued a severe warning to DIY DNA testing firm 23andMe, telling the company to stop advertising its at-home genetic testing kit that the feds say is misleading, dangerous, and illegal. According to the FDA, 23andMe has failed to prove that their testing correctly identifies genetic proclivities towards disease, and encourages users to self-diagnose — often incorrectly, and sometimes dangerously.

The FDA posted its letter to the company on its website. According to their findings, 23andMe has been blowing government regulation off for months and the FDA is not going to take it anymore. An excerpt:

Months after you submitted your 510(k)s and 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. It is now eleven months later, and you have yet to provide FDA with any new information about these tests.  You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. 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 PGS’s uses and consumer base without obtaining marketing authorization from FDA.

23andMe responded publicly to the letter, saying today: 

We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

23andMe’s website boasts that the company uses your DNA — that customers send to them in the mail for testing — to “help you know more about your health so you can take an active role in managing it. With reports on over 240+ health conditions and traits, here are a few of the things you'll learn about you: carrier status, health risks, drug response, health tools, inherited traits, scientific advances.” The company was founded in 2006 by CEO Ann Wojcicki (who is married to, but separated from, Google co-founder Sergey Brin) and others. According to Bloomberg Businessweek, 23andMe boosted its database to 400,000 customers when it slashed the price of its testing kit down to $99.

This article is from the archive of our partner The Wire.