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The health reports have only been withdrawn for customers who have ordered a 23andMe test from 22nd November onwards.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

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

The official press release can be found here:

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:

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:

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: 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


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?

Anonymous said...

They probably stepped on big pharma's toes so the big pharma had the FDA shut it down. What I don't get is why don't they open up a subsidiary in another country to interpret the data.

Debbie Kennett said...

23andMe are working with the FDA to get regulatory approval. See this blog post:

However, I suspect it will be a slow process.

I believe that 23andMe are looking into setting up shop somewhere in Europe. That would certainly help to bring down the cost of the test. At the moment it costs almost as much to send the kits by Fedex to Europe as it does to buy the test itself.

GeoFan49 said...

Still waiting? Looking for alternatives. It seems very strange, how can the FDA get away with this? Meanwhile, there are other sources such as Promethease to use as an alternative.

Debbie Kennett said...

23andMe have already restored their health reports in the UK and Canada:

23andMe are supposed to be working through the regulatory process with the FDA and I'm sure the health reports will be restored in other countries before too long as well.