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FDA Freezes Marketing of 23andMe Genetic Tests

The FDA has ordered genetic test-kit purveyor 23andMe to stop marketing the kit. The agency alleges that the company, run by Anne Wojcicki, gazillionaire wife of Sergey Brin, is wading into murky water by touting the kit as a disease diagnosis tool without regulatory clearance in violation of the Federal Food, Drug and Cosmetic Act. According to the agency, the kit falls under the heading of a regulated medical device.

Read the whole story at Consumerist »

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