whats known and unknown

DNA Testing Startup 23andMe Hits A Snag As FDA Shuts Down Sales Of Home Testing Kit

on November 25, 2013


The U.S. Food and Drug Administration has ordered 23andMe, the genomic startup co-founded by Anne Wojcicki, Linda Avey and Paul Cusenza in 2006, to stop selling its at-home DNA testing kits as of November 22. As Bloomberg reports, a letter from the FDA sent to the company made public today classifies the kit as a medical device and outlines that it required regulatory approval before being sold.

Part of 23andMe’s mission is to help people assess their risk and the risk of their offspring for genetic, inheritable diseases and conditions, and that’s what the FDA has apparently taken issue with. Determining medical risk classifies the kit as a medical device, the organization says, even if that’s not the sole use 23andMe’s service (many get tested simply out of curiosity, or to help support ongoing research initiatives). 23andMe’s database of 400,000 total individuals is a veritable treasure trove of info for…

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