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FDA Warns Genetic Test Maker 23andMe

Mon, 11/25/2013 - 3:26pm
The Associated Press

Federal health regulators have ordered genetic testing company 23andMe to stop selling its main product because it has not been proven safe and effective.

In a harshly worded warning letter, the FDA says the Silicon Valley company has not provided evidence that its test can predict the risks of developing various diseases, as its marketing materials claim. The FDA first warned 23andMe that its technology needed to be federally approved in 2010.

23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in 23andMe since its founding in 2006.

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