DNA Testers On Notice As FDA Warns Wife Of Google's Brin

Law360, New York (November 25, 2013, 6:29 PM EST) -- The U.S. Food and Drug Administration on Monday delivered a high-profile jolt to the booming field of personalized medicine by ordering a halt to sales of genetic tests by the wife of Google Inc. co-founder Sergey Brin, putting manufacturers on notice that regulators are getting tough after years of leeway, experts say.

In a warning letter to 23andMe Inc., FDA demanded that the company “immediately discontinue” sales of a $99 DNA-screening kit, saying the unapproved product could result in dangerous false positives or negatives.

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