A Note to Our Customers Regarding the FDA

By Anne Wojcicki

Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US.23andMe_Logo_blog

This is also the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives 23andMe a regulatory framework for future submissions. While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering.

The FDA has been incredibly responsive throughout our review and the agency has demonstrated its support for direct to consumer genetic testing. We will continue to work with the FDA to ensure that all future health submissions meet the agency’s standards.

It’s been a challenging and exciting time for consumer genetics. Our customers support and the stories they shared along the way make my job worthwhile.  I will continue to provide our customers with updates on our blog and by email. We’ve also posted more information about the authorization here.

I want to thank our customers for their ongoing support during this process.


  • paulappleton

    The journey of a thousand miles, begins with a single step. Good for you, I am glad FDA will ultimately open gate for direct to consumer, genetic testing.

  • Alexander Gee

    Excellent news team. We know how hard you have been working on this.

  • FreedomsAdvocate

    Excuse me, but what the hell authority does the FDA have over a non-invasive medical test requested by a private individual about their own body from a private company?

    • Natashacbk

      I’ve been asking the same question.

  • Jawaralal_Schwartz

    Question for the proprietor: when you finally get FDA approval to disclose health-related information, will you provide that information (free, gratis, for no money) to people who have only been able to obtain ancestry results because of the FDA order? The kit was gift and the ancestry results have some value, but I never would have bought your product without health information.

    • 23blog

      Our intent is to provide health reports to those customers who only now receive ancestry results when and if we get FDA clearance . But when that will be and what we will be able to report to customers at that time we do not yet know.

      • Jawaralal_Schwartz

        The question is, again, will you charge additional for the health results when you can provide them, or, give the health results free to those who have only been given ancestry results?

        • 23blog

          We don’t intend on charging current ancestry only customers additional fees to view health results when and if we get FDA clearance to return those results to customers.

    • Andrew Zimmerman

      I’m sure they’ll just enable it.

  • AdaNja

    No, the reason being that it is a US company and bound by the FDA laws. It is registered and operates from the USA. They could not have done that. If they had a separate branch located in Europe or elsewhere which analyses the kit and all that, then yes sure.

    • Andrew Zimmerman

      That’s what they should do. Just move everything to Ireland like all of the other companies, until the USA changes.

  • 23blog

    Our understanding is that because it is being ordered through a doctor that it’s handled differently, as what’s called a Lab Developed Test. The test is not meant for diagnosis but meant for the doctor to gather information about their patient. The FDA has had some discussion recently about regulating LDTs, but to your point the biggest difference is that we provide information directly to consumers and not through a third party.

  • Rich Mesek

    23 and me doesn’t explain what bloom carrier is nor what exactly this fda approval means in this”announcement”. Perhaps they need an announcement to explain their announcement LOL

  • Chuck Conlin

    Apparently the FDA (and some people commenting here) think we are too stupid to handle information about our health. It should be laughable in “the land of the free”. The FDA is protecting me from information about my health!!! The FDA and the government in general are power hungry and don’t care about us, the people. I wrote to the FDA and didn’t get even the courtesy of a reply.

  • 23blog

    We simply offered customers the opportunity to use MyHeritage to manage their family trees. We had a family tree tool that we no longer support. If you’d like to learn more go here:

    • Melba DeLancy Holliday

      Thank you for your answer. Today I received this info from 23and Me.
      I will now pass info to my Sis and instruct her on its use.

      Thank you
      Melba Holliday

  • Amanda Kennerly

    I was one of the last women to receive a full genetic report before the FDA shut it down for political reasons of the nanny state.. I bitterly resent that my own government feels I cannot handle the truth about my own DNA and I am not part of the sheeple seeking a sheperd to interpret my own information that may be too much for my poor little head. Now my friend has breast cancer, two daughters, and wants to know if she has the genes to worry about, but in our area, a test for her costs $3000, and of course her Obamacare won’t cover it. For our health’s sake, and for the future of this nation to have the free exchange of scientific data, please keep fighting for affordable genetic testing for us. Amanda B. Kennerly

  • Sidd

    Why not just play the FDA’s dirty game and pour hundreds of thousands of dollars into lobbying for change? Pharmaceutical companies compensate FDA executives to expedite drug approvals, even despite poor evidence of safety and efficacy. I assume google has a soul, so they wouldn’t succumb to the same practices of other corporations.

    Giving consumers access to detailed health reports is a just cause, as it would give people the means to mitigate the risk of certain diseases and cancers through lifestyle changes, as opposed to prescription medications and surgical procedures. Deaths from adverse drug reactions are now the fourth leading cause of death in the United States.

    I think everyone needs to understand the rationale behind the FDA’s policy and the role that pharmaceutical companies play in all of this. By definition, the FDA is merely an extension of the pharmaceutical branches in this country because of their financial ties to them. A large percentage of the FDA’s funding comes from pharmaceutical companies (and not our tax dollars). This means that drug approvals are only based on the information provided to them by the pharmaceutical companies. There is no independent third party that verifies the clinical evidence. For more on this, I would suggest reading Dr.Ben Goldacre’s analysis on the role that industry influence plays in the drug approval process.

    In other words, everyone has their price. I suggest you pick up on this, 23andme.

    • Andrew Zimmerman

      It is not right for the Government to block the people from getting what they want, as long as it does not interfere with the liberties of others.

  • Stephen Holder

    Hi, seems like a step in the correct direction. I live in New Zealand, does the FDA ruling affect me too? I assume that the ruling is over all US operations as you are based there, right?

    My wife’s doctor has recommended you to us but if you are unable to provide the medical markers it appears that there is little point. It’s pretty frustrating that the FDA can effect the potential of healing for non US people isn’t it.

    Many thanks

  • Andrew Zimmerman

    Hey thanks. Didn’t know about this.

  • Andrew Zimmerman

    Sorry but the Rights were not given by the government. They were Inherent.

    • Bob Bennett


  • Andrew Zimmerman

    Government knows best.

  • Andrew Zimmerman

    We’ll just wait 5 years until their department has reviewed the drug.


    If i get the test today, while genetic reports are prohibited, will I get the report sent to me when they are approved, or do I have to pay the $99 fee again?

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