23andMe to work with FDA for approval

This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

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

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