23andMe Update

I have not talked about the 23andMe and FDA issue, but did see an update when I logged into the 23andMe website. It does allow people who purchased the test before November 22, 2013 to access their health results.

Here’s a link to the ancestry only notice, but you will see it if you are a customer and try logging in on the 23andMe.com page.

https://www.23andme.com/ancestry-only-notice/

Welcome to 23andMe.

At this time, we have suspended our health-related genetic tests to comply 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 button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, 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.

– – – –

There’s a green I understand button you have to click on before you can log on.

Here is the original FDA letter to 23andMe

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

Initial response from 23andMe

http://mediacenter.23andme.com/press-releases/fda-letter-2013

Follow-up by 23andMe’s CEO

http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme

Most people did not bother reading the FDA letter and do not understand why 23andMe received the letter from FDA. The issues date back to 2010 or earlier and 23andMe had responded to the FDA for 6 months.

Existing customers should download their results from the website, especially the health results if they are still there.

There is additional information available under the Health tab

https://www.23andme.com/health

It mentions a refund option for those who purchased the kit on or after November 22, 2013.

 

 

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