23andMe Provides An Update Regarding FDA’s Review

By Anne Wojcicki

After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review 23andMe_Logo_blogprocesses.

23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers.  I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future.  Our goal is to work cooperatively with the FDA to provide that opportunity.

We also want to make clear that we stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.

As we work with the FDA to get clearance, there will be some significant changes to the site.  Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.

Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.

This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team.

Research is and will continue to be a significant priority for the company.  The 500,000+ customers we have today have given us more than 250 million survey data points.  You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014.

23andMe will also continue educational efforts to consumers, physicians and other health providers as we believe genetics will be an increasingly important part of all of our lives.

Finally, I want to say thank you to our customers for your support and your stories.  Many of you have written in about how 23andMe has changed your life.  It is rewarding for me and all the employees at 23andMe to serve our customers.  I am committed to 23andMe and committed to being a pioneer in the genetics revolution.






  • Jim E

    We purchased a kit before Nov 22nd but have not yet sent it in. Will the original medical results be available for that kit or not?

    Hope you can eventually get this all worked out!

    JE

    • ScottH

      Jim,
      No, if you bought on or after November 22nd, you will not get health results at this time. You can ask for a full refund however.

  • Holger Kraus

    I have ordered the kit just yesterday – which means I am affected by this policy change.
    In case I decide to go ahead and send in my DNA sample – will this mean it only gets tested for my ancestry markers or will it still receive the full set of testing but this information will simply (and hopefully temporarily) not be available to me for now?
    In case it receives the full testing: Is there any rough estimate on when the FDA’s terms will be met so I can get access to my health information? (Are we talking days? Weeks? Months? Years?)

    My sole intention of getting genetic testing from 23andMe was getting my health information. I see little point in going ahead with my order (which is still within the 24h cancellation period and I assume as well eligible for a refund)

    I am looking forward to your reply so I know whether or not to cancel my order and how to proceed in general.

    Thanks,
    Holger

    • ScottH

      Holger, We don’t have a firm timeline as to when we might be able to again offer health reports to customers. I wish I could give you a specific answer but I don’t have one. Your decision about whether to go forward or not is a tough one. We are offering full refunds for customers, who like you bought with the intent of getting health results. Also just to clarify something in your comment. We are still processing samples and you can download all of your raw data.

  • http://www.facebook.com/wdcguy Clinton Davis

    I appreciate your honesty and open communication, and I continue to believe in your work. I feel terrible about the disappointment and frustration you and your colleagues must feel. Keep the faith! :)

    • ScottH

      Clinton, Thanks for your comments.

  • Nancy

    This saddens me, I do hope for a change back in the near future. I sent a kit in today and have other one I’ve not used yet. I purchased both of these kits several months ago. Will I still be able to get health reports on the one I sent today and the one I’ve not used yet?

    • ScottH

      Nancy, If you purchased the kits before November 22nd then yes you will get both your health and ancestry results. We do hope that we can quickly move through the FDA process.

  • Margaret

    Typical of the federal government. They think that the way to help people is to limit their choices and access to information. I hope the FDA backs off and treats us like adults capable of making decisions based on the best information available.

  • John Stover

    Why did you wait until the FDA cut you off before you thought you might need to show some progress on this? You had enough time to make the rounds on the talk show circuit but you couldn’t find the time to comply with the FDA? Thousands of companies comply with the FDA every single day. Did you think they were just kidding around for the past 6 years? It’s time for the leadership of this company to get it together; you’re doing important work so please stop screwing it up.

  • http://about.me/mist Mike Strunin

    Are this new rules only for US customers?
    Or also international?

    I haven’t received refund email yet.

    • Scott23H

      Mike, It’s for all of our customers. If you haven’t received an email please contact our customer care. There’s a link in the post.

    • Carl

      Don’t get a refund. 23andMe still lets you download all your raw DNA data, so just use a 3rd party program like Promethease to analyse the raw data and generate a health report for you.

  • Camoleft

    Over the past few years, I have discussed and shared info from my 23andME with my doctor. Last visit, I noticed that there is a sign in his office offering genetic testing with just a simple swab. I guess the doctor thought it was a good idea, especially since his patients were already doing it on their own. However, there is no way that the information 23andMe provides would lead me to self diagnose or self treat a condition I may experience. I would ALWAYS need the guidance and assistance of trained professionals. It’s not like if I had that breast cancer gene, I could just schedule a mastectomy. DUH FDA!

  • Ronald Herring

    Kudos for you, the FDA could surely better direct their efforts to protecting Americans in so many more ways than the actions that they have taken. Your efforts to collect data cannot be minimized, they should instead be embraced. I originally bought the product to expand my genealogical research and I will continue to promote your product to others as I am sure MOST of your customers will do. I look forward to continue completing health related surveys as they become available again in the future.
    Best Wishes to a continued successful venture and we’re here to help you weather the storm.
    Ron Herring

  • Scott23H

    You won’t get health reports that include estimated genetic risks for certain health conditions as well as carrier status and traits. We hope to add those features back into the service with FDA approval. The ancestry level data looks at your Ancestry Composition, connects you to DNA relatives — close relatives and distant cousins — and it allows you to compare genomes. Your raw data is essentially all of SNP reads — your genotype for each of those markers. You can download that data explore it on your own.

  • Scott23H

    Ian, The change is tied to the purchase date not the date that the kit is returned.

  • Scott23H

    Joanne, If you haven’t received an email, first take a look in your spam folder to make sure it wasn’t automatically routed there. If you still don’t find it, go to the link that we’ve put up on the post and that will walk your through the process for a refund.
    Thanks.

    • Joanne Jourdain

      Hi Scott, please reread my message. I don’t want a refund as I am delighted with 23andMe. Thank you for your concern. Happy holidays!

  • Susan Friel-Williams

    I stand by 23andMe. Question however, since you are suspending Health Data an concentrating on genetic data, does that mean that you can now ship to states such as New York and Maryland that you could not previously? If so, let’s target NY for a sale!

    • Scott23H

      Susan,
      Your questions are on point, but at the moment I can’t answer your question. We’ll look into and let you know.
      Thanks.

      • jane snyder

        Scott and Susan – I live in Maryland, and would love to order a test legally. I’ll be watching for the answer eagerly. Thanks.

  • James lizotte

    I ordered mine on Nov. 25th and already sent it in. I mainly did it for the health results, so whats the odds this gets resolved in a couple weeks and I can see my health risk results?

    • Scott23H

      James,
      Because you ordered after the November 22nd FDA letter we cannot give you your health results. This isn’t an issue that will be resolves in a couple of weeks. We are deep into the process but it is hard to predict how long it will take to get through the FDA process.

      • aGuyWithOpinions

        Hey, Scott. I purchased my kit on Nov. 17th and mailed my sample on the 25th (the day the news broke about the letter). What am I going to get?

        • Scott23H

          The controlling issue is the date of purchase. You purchased before November 22nd, so you will get both your health and ancestry results.

        • aGuyWithOpinions

          Great! Thank you for answering questions here, Scott. ( https://www.23andme.com/health/ which gives an unequivocal statement to the same effect; I didn’t find that until after posting my question here.)

  • Mill Stone

    @ Carl… what you wrotte means i can still have the same result as before NOV 22 if i do it myslef once i get the result back? We ahave to go to those 3rd parties website and we will have the same information as before nov 22? just curious and confused. I bought 4 test 2 days ago! sucks1

  • James lizotte

    Great thanks! I guess I won’t get a refund then.

  • joshua kit

    How generous of you to “comply” with the FDA directive.

    • cs30109

      The FDA is totally wrong, and should be ashamed of their inexcusable waste of public resources pursuing this.

  • Marilyn Collins

    I recently bought 3 tests. I understand that I will not get my health results on these tests now. If the matter with the FDA is resolved in the future, will health results of tests done between 11/22/13 and the FDA compliance date in the future then be released?, or will we have to redo the tests post-compliance to receive health information?

    • Scott23H

      Marilyn, You would not have to retest under that scenario.

  • David D

    Can you explain why you are extending this restriction to your health
    report service to international customers? Does the FDA have the
    authority to prevent you from offering this service internationally and
    have they requested that you stop offering it worldwide? Apart from the
    rather high international shipping rates (why so high?!) I am sure there
    are many, like me, who would like to continue to receive all of the
    health information you previously provide.

    I would like to back
    Carl’s comment – there is a lot of information out there already for
    those that are restricted, and I would like to add http://opensnp.org to
    the list of useful sites (it allows you to upload your 23andme data
    too). I have yet to personally use 23andme (I planned to use it in the
    New Year), but i use these third party sites almost daily in my
    research, and find them invaluable.

    PS. Any thought about setting up in Europe?

    • Scott23H

      David, You make some valid points but it boils down to the fact that we are operating in the US and wish to engage in this process with the FDA in good faith. We believe ultimately we’ll be able to work through this process and again return health results to customers.

      • Jennifer Carole

        Okay – if I read between the lines here, if we have bought the test and turned it in but fall in this hideous window, you’ll still process everything you just won’t “release the data” until issues are resolved. Right? So you’ll have it we just have to wait for the g’ment once again, to add value (really means a ton of lawyers to write a ton of words to basically say it’s all on us – which we already know).

        • Scott23H

          Jennifer, We won’t be offering health reports at this time, but customers can still download their raw data.

  • Munna2002

    Is there a timeline on when the issue between FDA and 23andme might be resolved? If it will be resolved, will 23andme provide health analysis to customers who were restricted from seeing such info post-November 22nd?

    • Scott23H

      Munna, I wish we could tell you. All we can say right now is that we are committed to working through this and are already deep into the process. When we can be more specific we will.

  • Carl

    Will people who ordered after the 22nd of Nov, still be getting the “Traits” page (eye colour, hair colour, etc.), since that’s not related to health or disease?

    • Scott23H

      Carl, No we’ve removed all health results including traits and carrier status.

  • Carl

    It’s still worth getting the test because you can download the raw 23andMe data and run 3rd party programs on it (like Promethease) to generate a health report. It might not be as convenient or quite as good quality, but you can still get a good idea of your genetic health risks and traits. It would just be analysed by a different company, not 23andMe.

  • Robyn

    For those who have not yet received their results yet ordered their kits before November 22nd, is everything currently on hold? My kit was delivered back to the lab on the 22nd and it has yet to be marked as received.

    • Scott23H

      Robyn, No everything is not on hold. We are still busy processing kits.

  • Scott23H

    Daniel,
    Thanks for the note. The price isn’t going to change. Although you are correct that we are now giving less information back to customers, the cost of processing the sample is the same and we are reporting back the same amount of raw data. We understand that for some customers this just isn’t going to work, hence the refund policy.

  • Scott23H

    Mike, My answer to Marilyn was that you would not have to be retested under the scenario she described.

  • Richard Gao

    I ordered one kit on Nov. 25. What can I do to get health results? Help!

  • Allen

    My letter to Alberto Gutierrez at the FDA (author of the “Warning Letter” to 23andMe):

    Dear Mr. Gutierrez —

    In spite of the following, I generally appreciate most of the
    services the FDA provides for US citizens.

    However, even considering the agency’s well-known polygamist,
    common law marriage to big pharma and the AMA, I think your highly imaginative
    recent warning letter to the president of 23andMe, Inc. represents a trip far
    beyond common sense regulatory guideline enforcement and clearly into the realm
    of hit-man hired by those two jealous spouses.

    For example, I’m sure it would’ve been in the news if, for any
    reason, someone tried to perform surgery on themselves—that is, without a
    doctor’s involvement—for either breast or ovarian cancer, not to mention—as you
    did—any post-op chemo or radiation therapy. Are you serious?

    Having read through your letter, as many others now have, I would
    agree with the best comparative analogy I’ve read about it so far; that if you
    and the assumptive applications of FDA guidelines set forth in your letter are
    to be taken seriously, I would fully expect you to send a similar warning
    letter to every manufacturer of oral thermometers so all of us idiots will stop
    making wild assumptions and perhaps performing surgeries (and post-op
    therapies) on ourselves based solely on information about our body temperature.

    This kind of over-kill is just another demonstration that the FDA
    is at least, if not more interested in protecting the sacred turf
    of big pharma and the AMA from upstart “outsiders,” as it is in protecting the
    health of the public.

    I also think that more in-depth information is the best
    preventative medicine we can get, whether it comes from beyond your agency’s
    cartel members or not; although most likely if not. Towards that end, I
    hope 23andMe, Inc. is able to reword all of their accompanying product
    information in such a way as to escape the predatory tentacles of that cartel,
    via your agency, and provide us with basic information which we have every
    right to obtain. Admittedly, I’m not holding my breath until that happens.

    With all due respect Mr. Gutierrez, I know who’s paying your
    salary, but in this particular case whose best interests do you
    really think you’re working for? I don’t need a reply; that’s just for you to
    ponder.

    Sincerely —

  • Allen

    Ok. Now I see.

  • Vincent

    I purchased kits in December, and I’m from Canada. Why does this FDA ruling should apply to my tests? We have Health Canada here, and they’ve been silent about these things.

  • SocialMicrobe

    If the FDA is so worried about people self treating then they need to shut down WebMD because that is were all the crazy self diagnosed and treaters go…

  • Matthieu Heimer

    This sucks, it kills the primary reason I wanted to use your service.

  • Scott23H

    Anna, Yes you’ll still be able to see your health results.

  • Scott23H

    Rose, You don’t have to do anything to allow for your sample to continue to be processed. You’ve purchased and sent in your sample, if you don’t ask for a refund we will simply proceed with processing it. We typically let people know when their sample is received by the lab and let them know when your results are ready. We appreciate your business, but we cannot offer the health results at this time. Part of the reason we are offering a full refund is for people like you who purchased with the understanding that they would get both health and ancestry information. We apologize that we cannot continue to do that at this time, but that decision was not in our hands.

  • Scott23H

    Jonathan, I’m sorry to say that individuals who ordered on or after Nov. 22nd, the day we received the FDA letter, will not get health results. We are offering full refunds (including shipping) if you would like.

  • Scott23H

    Yes Aaron, If you purchased before the 22nd you will get health and ancestry reports.

  • Scott23H

    John, You’re sending this message to the blog. You need talk to our customer care team. Go here: https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box

  • Scott23H

    Jenny, We won’t be able to do updates until we get approval from the FDA for each individual report.

    • Cotay

      Scott, I’m very confused by all of this. I ordered my kit on November 8th and it was returned and received on November 18th. It is now at the lab as of December 4th. From the email I received, I was led to believe that I would still have access to all health-related information that was available prior to the FDA letter. Is that not the case?

      • Scott23H

        Cotay, You purchased before Nov. 22nd so you will have access to both health and ancestry reports. It may take a few weeks for the lab to process your sample.

  • Scott23H

    Mike, Yes the refund includes postage. You can biobank your sample but not if you get a refund. What we do is offer biobanking as part of the service. This is so that if we develop a new chip that you want to be sampled on you do not have to resubmit a sample. Your questions about Promethease I can’t answer. Obviously many of our customers have taken their raw data and done their own research using other services. Part of what we offered with our health reports were curated review of the scientific literature. We have criteria to reporting back risk that ensured that anything we reported back had to meet a certain threshold. I’m not sure what criteria Prometheus or others offer.

  • Scott23H

    Mike, The date in question is Nov. 22nd. We will continue to process samples in the same way. We will biobank samples if customers request it. The difference is that customers who purchased on or after November 22nd will not be getting health reports.

  • Scott23H

    Jonathan, No. If your ordered on or after Nov. 22nd you will not get health reports. Because many individuals ordered at that time expecting to get both ancestry and health information, we are offering those individuals a full refund.

  • Scott23H

    Inder,
    If you purchased before Nov. 22nd you will still receive health information.

  • Scott23H

    Frak,
    If you purchased before Nov. 22nd you will still get your health results. The purchase date is what is important.

  • Scott23H

    Darcy, You are not the first person to make this point, but we are based in the US. We are trying to work with the FDA because we ultimately believe it’s the best course of action.

  • Scott23H

    M.L. Harsens,
    At this time we are working with FDA and through their process. We believe they do have a role to play here. This is not the outcome we’d hoped for, but we’re optimistic that we can get through this process and offer our customers health reports again.

  • Scott23H

    Briylaln,
    If you ordered on or after Nov. 22nd and ask for a refund you will get a full refund including postage.

  • Scott23H

    Mark,
    We will continue with our research mission. We are involved in several specific research areas and will will continue to publish based on those studies.

  • Scott23H

    Deb,
    No. We take customer privacy very seriously. Your data is not going to be turned over to the FDA.

  • Scott23H

    Rose, The issue isn’t going to be resolved by Christmas. I don’t imagine that we would open up the refund policy so that you would get results and then wait around a few months to see what happens and still be able to get a refund after that time. That said, if you want a specific answer to that question it would be best to contact customer care. (You should have gotten that contact information in an email regarding the refund offer.)

  • Scott23H

    Andreas,
    We won’t be able to update health results until we get approval from the FDA for those results. We will continue our research.

  • Scott23H

    Maris, Yes. If you purchased before Nov. 22nd, even if you haven’t sent the sample in yet, you will still get both health and ancestry results.

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