The FDA Just OK'd 23AndMe To Test For One Syndrome

February 20, 2015 6:10 PM

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The FDA just gave consumer genetics testing company 23AndMe permission to sell tests for Bloom syndrome—a disease associated with shortened height and an increased cancer risk. This is the first genetic feature the company is legally allowed to test for since the FDA shut down 23AndMe’s genetic analysis service for consumers back in 2013 out of concern for test accuracy. The FDA announcement also gave the test class II status, meaning it was no longer classified as a medical device and is now exempt from pre-market review by the agency.

So is the FDA's announcement an acknowledgment that 23AndMe is finally on the right track for providing direct-to-consumer genetic testing?

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