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FDA warns Google-backed 23andMe to halt DNA testing services

25
Nov
2013

The U.S. Food and Drug Administration has warned 23andMe Inc, a company backed by Google Inc, to halt sales of its genetic testing services because they have not received regulatory clearance. 23andMe, which was founded in 2006 by Anne Wojcicki with the backing of Google, sells DNA testing services that the company says detect a range of genetic mutations and provide information about a persons health risks. Wojcicki recently separated from her husband, Sergey Brin, a co-founder of Google. In a warning letter dated November 22 and released on Monday, the FDA said it considers the companys product a medical device that therefore requires regulatory clearance, as FDA has explained to you on numerous occasions. The privately held company, which is based in Mountain View, California, did not immediately respond to a request for comment left before business hours.

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