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FDA Gives 23andMe The Green Light



As a user of 23andMe since 2008, I’ve been closely following the company, especially since the FDA told them in 2013 to stop marketing their personal genetics testing service. At last, the FDA has given 23andMe the green light. Not surprisingly, the positive news pushed the cost of the genetics test from $99 to $199. 

Here’s the email I received on October 21, 2015:

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Subject: CEO Update – Exciting News

Dear Eugene,

Today marks a great milestone in the history of personal genetics. I am thrilled to let you know that 23andMe is now the first and only genetic service available directly to you that includes reports that meet FDA standards.

After nearly two years of work with the FDA, extensive user comprehension testing and a complete redesign, 23andMe is launching an entirely new experience that includes carrier status, wellness, trait and ancestry reports. We have also developed new and improved tools to share and compare your genetics with friends and family – and for those of you participating in research, we will provide new insights to explore.

As one of our earlier customers, you will continue to have access to your current health reports. The new experience will include redesigned versions of many of the same health and ancestry reports that you currently have. We have also added some new features and tools.

Our team will be rolling out the new experience to you by early next year. We will send you an email when your account is updated.

If you have any questions on the new experience, you can visit our new FAQ page. Additionally, we have updated our Privacy Statement and Terms of Service to support the new features, which I encourage you to read.

We are committed to bringing you a world class service which provides you with ongoing updates. The genetics revolution is here and we are excited to enable customers like you to keep learning about your DNA. Today is only the beginning!

Anne Wojcicki

CEO, 23andMe

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In an industry in which we must abide by strict regulations in order to market to the public, this news is a welcome and promising step forward in the advancement of genetics and genomics.

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Eugene Sefanov

Director, Industry and Regional Marketing

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