Friday, 6 December 2013

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The health reports have only been withdrawn for customers who have ordered a 23andMe test from 22nd November onwards.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.

© 2013 Debbie Kennett

1 comment:

Anonymous said...

Screw you FDA! It's my own business if I want this company to interpret my data for me. I have type II diabetes and I want to know what else I could possibly pass on to my kids. Now I'll never know thanks to the fascists at the FDA. Did 23andme not pay the FDA tax? What's really going on here?