23andMe reboots genetic health testing, now with FDA approval

23andMe's genetic testing kit. (credit: Cyrus Farivar)

After a nearly two-year hiatus from providing medical data to customers, the genetic testing company 23andMe announced that its trimmed down DNA-based health analysis has been approved by the US Food and Drug Administration.

The revamped reports of genetic tendencies, plucked from spit samples, will not offer customers insights on their risks of developing a range medical conditions, such as Alzheimer’s disease, as previous testing did. Instead, the new test focuses on informing customers about their ancestry, the mutations that could pose disease risks to their children, and traits such as their reaction to alcohol and potential for hair loss.

The lighter list of health information follows a battle with the FDA that began back in 2009—a battle the agency won in 2013. In November of that year, the FDA sent 23andMe a stern letter informing the company that its genetic testing was not properly approved by the agency and that it needed to stop selling the tests immediately.

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