23andMe update, third party tools and alternative personal genomics companies

Following on from the warning letter received by 23andMe from the FDA, the company have now announced that in order to comply with the FDA's requirements new customers will not receive health reports "while the company moves forward with the agency’s regulatory review". The ancestry reports are not affected, and new customers will also have access to their raw data files. Raw data files can be uploaded to third-party services such as Promethease or Interpretome where you can generate your own health reports. A full list of autosomal DNA tools can be found in the ISOGG Wiki:

www.isogg.org/wiki/Autosomal DNA tools

The FDA is not concerned with customers interpreting their own raw data and as far I understand these third-party tools do not fall under the FDA's remit.

The health reports have only been withdrawn for customers who have ordered a 23andMe test from 22nd November onwards.  This was the date when the warning letter was received from the FDA. Existing customers who ordered a test before 22nd November will continue to have access to their health reports.

Anne Wojcicki of 23andMe has posted a personal message to 23andMe users on the company blog:

http://blog.23andme.com/news/23andme-provides-an-update-regarding-fdas-review/

More detailed FAQs can be found on the 23andMe website:

https://23andme.zendesk.com/entries/23273619-FDA-Update-December-5th

The official press release can be found here:

http://mediacenter.23andme.com/press-releases/23andme-inc-provides-update-on-fda-regulatory-review/

Blaine Bettinger, who writes the Genetic Genealogist blog, has provided some useful commentary on the latest developments and links to other posts on the subject:

http://www.thegeneticgenealogist.com/2013/12/06/23andme-will-continue-to-sell-genetic-tests-for-ancestry/

Margaret A. Hamburg, a Commissioner for Food and Drugs at the FDA, has written a letter to the Wall Street Journal in which she states that the FDA "remain committed to continuing our ongoing dialogue with the company in order to bring a safe, effective and trusted product to the market". The full letter can be read here:

http://online.wsj.com/news/articles/SB10001424052702304011304579222111609444156

It is not yet known how long the regulatory process will take but I hope that a resolution will be reached sooner rather than later and that 23andMe will once again be able to market their DNA testing service.

In the meantime if you are interested in getting your DNA tested for the health reports there are a number of different companies outside the US which offer a similar service to 23andMe. A full list can be found in the ISOGG Wiki:

www.isogg.org/wiki/List of personal genomics companies

All the other American companies now require that the testing is done through a doctor. However, many of the companies in other countries still offer a direct-to-consumer service. Unfortunately, none of the other personal genomics companies have the advantage of a large database and a vibrant community forum which are the biggest benefits of the 23andMe service.

For the background on the 23andMe story read my earlier blog post on 23andMe and the FDA.

Update December 2014
The 23andMe health reports are now available once again in the UK and in Canada though in a somewhat pared down form. For further information see my blog post 23andMe relaunches health reports in the UK. See also the article 23andMe launches personal genome service in the UK by Philippa Brice of the PHG Foundation.

© 2013 Debbie Kennett

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.