Following demands issued by the US Food and Drug Administration late last month, 23andMe has ceased all health-related genetic testing until further notice.
In a November 22 letter to 23andMe, the FDA explained that it was “concerned about the public health consequences of inaccurate results from the [23andMe] device”, adding that “the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work”. The FDA went on to suggest that false positives or false negatives on the test could lead to startling results; people take these tests seriously, guys!
After that letter arrived, 23andMe immediately stopped marketing its health tests, but now it’s no longer performing them either. Customers that purchased kits on or before November 21 can still receive a health analysis — but with the FDA knocking on the door and claiming they may not be accurate, perhaps they’d be better served by not bothering for now.
Anyone having bought a test after November 22 will only have access to ancestry information and raw test results without analysis; it’s not clear if there’s a refund policy in place yet. 23andMe co-founder Anne Wojcicki is understandably “highly disappointed“, but she claims the company is “committed to finding the right regulatory path”. Uh, yeah, good. But couldn’t they have nailed that when they started out six years ago? [23andMe]