Genetic test maker 23andMe stops marketing after FDA warning

(Reuters) - Home genetic test maker 23andMe, which is backed by Google Inc, stopped marketing its products last week after the U.S. Food and Drug Administration warned that it did not have regulatory approval to do so, a company spokeswoman said. The FDA said last week it had sent a warning letter to the company on November 22 stating that products designed to diagnose, mitigate or prevent disease were medical devices that required regulatory clearance. Company founder Anne Wojcicki said in a November 26 blog post that the company had been talking to the FDA since 2008 and had submitted its first application for clearance in July last year, followed by another submission in September. "We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well," Wojcicki wrote in the post.

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