23andMe gets FDA approval to sell genetic test kit

February 20, 2015 6:04 PM

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23andMe gets FDA approval to sell genetic test kit

This week, the Food and Drug Administration approved the company's direct-to-consumer genetic carrier test for market -- a stark reversal of opinion. In 2013, regulators sent 23andMe a letter warning the company to stop marketing its DNA health analysis offerings until further review.

But FDA officials announced Thursday they are exempting genetic carrier screening from premarket reviews, paving the way for products similar to 23andMe's to enter the market. The new FDA decision will be subject to a 30-day public comment period before it is finalized.

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