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FDA Grants 23andMe Approval to Sell Test for Rare Genetic Condition

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In 2013, 23andMe was delivered a crushing blow when the FDA ordered the genomics startup to stop selling its DNA testing kits to the public.

23andMe | YouTube

Up until that point, the company had been analyzing consumers' personal genomes, sent via mail-in spit kits, in order to provide detailed summaries of their genetic risk for a host of common diseases; with the FDA's ban, overnight the company became a glorified version of Ancestry.com.

Now, the FDA is easing its position, if ever so slightly, having granted 23andMe permission to sell a genetic test for makers of Bloom syndrome, a rare genetic disorder characterized by sun-sensitivity, short stature and an increased risk of cancer.

Related: 23andMe's Database of Genetic Information Is Going to Make It Lots of Money

As 23andMe cofounder Anne Wojcicki notes in a blog post announcing the news, this marks the first time the FDA has approved the marketing of a "direct-to-consumer" genetic test. Taken alone, it's a small step, but it is also points to a possible larger shift in the way the FDA may approach the marketing of additional tests for genetic diseases in the future.

The FDA's decision "gives 23andMe a regulatory framework for future submissions," Wojcicki writes. "While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering."

Related: In Taking Aim at 23andMe, Regulators Missed the Mark

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