23andMe and the FDA

The big news in the genetic genealogy world this week is the announcement that the personal genomics company 23andMe have received a stern warning letter from the FDA in which they were told that they "must immediately discontinue marketing the PGS [Personal Genome Service] until such time as it receives FDA marketing authorization for the device". However,  I note that despite the warning letter 23andMe have not withdrawn their test from sale.

This is the 23andMe ad which has been shown on national TV in the US which probably sparked the FDA's action. It seems to me inappropriate to advertise such a product on the television and I can understand the FDA's concern.

There have been many excellent articles and blog posts covering all sides of the debate so I won't comment here but will instead refer you to the best resources for further reading.

Blaine Bettinger, who writes The Genetic Genealogist blog, has given his take on the story and provided a very useful selection of links to the most interesting commentary on the subject. His post can be found here. If you are interested in the implications of the FDA's actions it's well worth reading all these links.

The journalist David Dobbs has also been tracking the coverage of the story and he has summarised all the different viewpoints and provided an extensive selection of links in his blog post FDA muzzles 23andMe after talks break down.

If you only have time to read one article on the subject I recommend reading Michael Eisen's thoughtful post FDA vs. 23andMe: how do we want genetic testing to be regulated. Michael Eisen's views most closely align with my own thoughts on the matter.

It will be interesting to see what happens in the next couple of weeks. I'm not expecting the FDA to shut down 23andMe but it might be that some of the health reports are redacted until such time as an agreement can be reached. Nevertheless it's a good idea to ensure that you have downloaded your raw data and saved the health reports that are of particular relevance. Some of the health reports can be saved as PDF files. For other reports you will need to save screenshots. If you've tested with 23andMe for genealogy purposes you might also like to take advantage of the Family Tree DNA sale to transfer your results to the FTDNA's Family Finder database. The transfer will cost $49 until the end of the year (the usual price is $69).

You can read my series of articles on my own 23andMe test using the links on this page.