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23andMe Suspends Health-Related Genetic Tests

23andme suspends health

We seem to have part of the answer as to what 23andMe will be doing in the short term.  Tonight when I went to the 23andMe site, I was greeted with this message.

In case it’s too small to read, it says:

Welcome to 23andMe.

At this time, we have suspended our health-related genetic tests to comply immediately with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.

We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.

If you are an existing customer please click the link below and then go to the health page for additional information. If you are a customer that purchased before 11/22/13, you will still have access to your health-related results.

We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.

Upon entering the site, please confirm you understand the new changes in our services.

I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports.  However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization.

I clicked on “I Understand” and was then taken to the normal sign on screen where their test kit is marketed solely as a genetic genealogy kit, with all mention of health removed.

After signing on, the health button on the main page is gone, but by clicking on “My Results” I can still see the Health Overview and proceed from there.  They mentioned additional information on the Health page, but I did not see anything additional.  Perhaps more is yet to come.

I do notice that the Research Surveys, Health Profile, and Key Health Recommendations are still present and the health reports/interpretation portions are still there in my account.  I was a customer prior to November 22, 2013.  But still, I’m surprised that all of the health surveys and questions remain.  They are clearly still data-gathering with their existing clients, so obviously hopeful about the FDA resolution.

It appears that the genetic genealogy portion is “safe,” for now, although we don’t know what the future holds for 23andMe as they move through the regulatory process with the FDA.  I also wonder if the genetic genealogy marketspace, which has never been a priority to them, can financially sustain them long enough to complete the FDA process.  Part of that answer would likely rest upon how long the process takes and the depth of their pockets.  So far, they are 5 years and counting, but we don’t know how far along they are in the process.  Perhaps additional information will be forthcoming as the deadline of December 13, 15 or 16, depending on how you count, approaches.

I would still suggest downloading your information, just in case, and I wouldn’t wait until the last minute.  No matter how well intentioned they are, they may find themselves in a situation where they cannot provide extensive notification about impending changes.

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