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.

  • Scott23H

    Eddie, No spin related to refunds. Although we did not get them done as quickly as we wanted, you should have gotten your refund by now.

  • It’s another example of what some refer to as the “Nanny State.” You know, that, “We want to protect you from yourself, and nanny knows best!” attitude? This is actually preventing access to useful health information, which we own because it’s a part of our body; hence the 4th amendment protects this as a civil right.

    I have MS and other health issues. I exist on TONS of meds and I want to cut that number down and prepare my body for stem cell treatments in the future. The meds are killing me, quite literally. If I could refine my meds to what is best for me as an individual, and someone prevents me from doing so, that seems to me to be “Preventing safe access to medication.” (see safe access org)

    The violations of civil liberty are abundantly clear imo!

    This is marketing Bullshit! I hope the companies providing this service have a game plan!

  • Scott23H

    Daniel, If you purchased before November 22nd you will get health and ancestry results. I believe this was the answer we gave you previously so I’m not sure if there was something else you are asking.

  • Joan Dolores Robinson

    The only thing the FDA is “protecting” are the outrageous profits that doctors and DNA testing companies have enjoyed until 23andMe came upon the scene with their affordable pricing.
    I hope 23andMe is in the process of hiring or finding pro-bono attorney help (think of the beneficial publicity for these lawyers), and has already contacted the ACLU regarding the usurping of individual’s rights to their own genome results. The FDA has approved many medicines and devices that later proved to be extremely harmful or fatal to the public. (They won’t ban cigarettes altogether because big tobacco pays them to keep that industry alive.) People, rise up and demand the release of 23andMe from imprisonment. Let’s send a blizzard of letters to: Division of Dockets & Management (HFA-305), Food & Drug Administration, 5630 Fishers Lane, Room 1061,Rockville, MD 20852. . Also, hit the FDA Administration at 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, or phone 1-888-463-6332 for general information. Maybe we can get some individual names, which is always more fruitful. Let’s not let the FDA get away with this one.

  • Scott23H

    Thanks for your note. Right now we are attempting to work with the FDA through this process. We will keep you up to date and let our customers know of any new developments.

  • Lightboy

    I am sorry for US citizens and companies that have to deal with the FDA. I have a question, I was about to purchase 2 kits when I saw what happened, and not having access to health results and only getting ancestors raw data… well, that’s not what I was looking for. As I am an European Citizen living in Europe and purchasing the kit from Europe, is there any option for me to have the results without those restrictions imposed by the FDA?

  • Valerie Olague

    I just want to share that this must be part of the broader effort the FDA is making to try to make Electronic Health Record software fall under the category of “medical device”. It is just nonsensical. Read how some healthcare providers and lawmakers are fighting back.

  • misterfunpants

    It takes a very special person to write a sarcastic letter to a politician.

  • Surprised no one has asked if there is a solution outside of the US we can gain the same answers from that 23andme use to be able to deliver.

  • Scott23H

    Traits are also part of the review so the results do not currently include traits.

  • Scott23H

    No we would not be able to do that. We hope to be able to again offer health results when we complete the FDA process, but at the moment we do not offer health results for new customers.

  • NN

    Move to another country. The FDA will not let you in peace here

  • healingnavigator

    no they would not. many patients are told that no one else has had
    a sensitivity to that particular drug. The patient needs to take control and decide which drugs he is willing to take and be told of all problems these drugs cause. If you look at most drugs they all cause damage to kidneys and liver, two most important organs in our body. But don’t worry after the drugs damage these organs you can get on the list for transplant…

  • healingnavigator

    Look at stats. 2012 29.1 mil have diabetes. It was around 18 mil in 2010. The cost for this is 245 billion dollars a year…The diabetic educators are still counting calories and have not changed their info on teaching. However, only the ADA can teach diabetics. iF you have diabetes it can damage every organ in your body. I don’t know where you live but if you are a health professional you cannot miss these stats.

  • Tonie

    a little sad about not finding out medical history but still very excited! I have looked for my dad for a very long time & finally found his family, he died in 1997 but I still have 3 half brothers…one brother & I are going to take the test to make sure we are a match & that will tell me if he really was my dad. I still cant believe this happening! Thank you!

    • 23blog

      We’re happy that you were able to connect with your half brothers.

  • Natashacbk

    I am a little unsure of how a genetic test falls under FDA jurisdiction. This is an information product, not a drug or a form of therapy. I’m just not seeing the connection here.

  • lauklejs

    I whole-heartedly agree that the FDA is wrong here. OTOH this is one of the VERY VERY VERY Few true examples of nanny state–maybe the only 1 IMO. In particular for those with selective amnesia, I would like to remind everyone that America had the fewest thalidomide babies of any western nation because of the FDA doing its job.

  • 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

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