Landmark decision: FDA Approves 23andMe Genetic Test

23andMe CEO, Anne Wojcicki, just emailed 23andMe customers (me included) with the big news that the FDA has approved the company to offer Bloom syndrome carrier status reporting.

As Wojcicki points out, this is the first time ever that the FDA has granted authorization of a direct-to-consumer genetic test. This is a huge deal.

Why Bloom syndrome? Why now? What else is coming? A lot of interesting questions.

Update: Here is the FDA statement on the authorization including this key requirement: “If sold over the counter, the FDA is also requiring 23andMe to provide information to consumers about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.”


Expect more incremental approvals from the FDA for additional 23andMe genetic reports.

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