23andMe, the health and ancestry startup, is slowly but surely moving along in the U.S. Food and Drug Administration’s regulatory review process to sell a medical device.
The FDA recently agreed to review 23andMe’s submission for a health report focused on Bloom syndrome, a rare condition that could result in death by the mid-20s. The review process typically takes around 90 days, but the report is part of the FDA’s regulatory review of 23andMe’s health product.
Last November, the FDA sent a warning letter to 23andMe, ordering it to stop marketing its saliva collection kits for its personal genome service.
There were, and are, two big issues: 23andMe is selling a medical device that is intended to diagnose diseases without approval from the FDA; and the company has failed to prove that it has clinically validated its personal genome service.
Read the full, original story: Seven Months After The FDA Cracked Down On 23andMe, There’s Still Hope For The Health And Genetic Testing Startup