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.
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.
23andMe has continued to sell kits that provide ancestry information and raw genetic data, but it still wants to be able to provide what is arguably its most valuable service: health information.
“Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions,” 23andMe Chief Legal and Regulatory Officer Kathy Hibbs wrote on the company’s blog. “More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them.”
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