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Apparently the rumors that 23andme were/are not even trying to win FDA approval to allow them to provide analyses of their data to clients was unfounded. They sent out an email update today advising that they have made some headway on winning approval. Here's part of what it included:
Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to offer the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to provide you with genetic health reports.
This is the first time the FDA has granted authorization to offer a direct-to-consumer genetic test, and it gives us a regulatory framework for future submissions. While this authorization is for a single carrier status test only, we are committed to providing you with health information once more tests have been through this process and we have a more comprehensive product offering.
The FDA has been incredibly responsive throughout our review and has demonstrated its support for direct-to-consumer genetic testing. We will continue to work with the agency to ensure that all future health submissions meet FDA standards.
How about that?
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
