Thursday, November 28, 2013

The FDA and 23andMe

For those who are interested in their DNA, the airwaves have been full of news and conjecture this week about a stern letter from the Food and Drug Administration to 23andMe. For a fair and balanced report, see http://www.thegeneticgenealogist.com/. Blaine Bettinger explains the issues rationally and refers to two other blogs for practical advice: http://www.legalgenealogist.com/blog/2013/11/26/fooling-with-fda/ and http://dna-explained.com/2013/11/25/fda-orders-23andme-to-discontinue-testing/.

The bottom line is that DNA testing for genealogy is not in question and neither is testing for health purposes. However, the interpretation of the health-related test results is at issue. The FDA requires proof that such interpretation is valid, and 23andMe has not yet provided this proof. Note that 23andMe is the only company at present that provides direct to consumer (DTC) testing for health-related issues.

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