To date, over half a million customers have taken the swab in return for detailed ancestry data and personalized information on 248 genetic traits and health conditions. The company, which launched in 2007 with substantial backing from Google, has been working closely — albeit slowly — with the FDA to ensure it complies with federal health and safety regulations. But the agency concluded in its recent warning letter that 23andMe was marketing a “device” that was “intended for use in the diagnosis of diseases or other conditions,” and as such, its marketing materials required pre-approval from the FDA, which includes extensive research studies.
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In the latest dust-up, the U.S. Food and Drug Administration (FDA) last month ordered startup 23andMe to stop marketing its $99 genetic analysis kit, just before the Christmas shopping season kicked into high gear.
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