An FDA Update For 23andMe Customers

Over the last few months we’ve heard from many of you asking about where 23andMe stands in the FDA authorization process, so here is the latest.23andMe_Logo_blog

To remind you, back in November the FDA ordered 23andMe to stop returning health results to new customers until we completed the agency’s regulatory review process. 23andMe quickly complied.

“My main priority is resolution with the FDA,” our CEO and co-founder Anne Wojcicki said recently.

Despite 23andMe’s intense attention on this regulatory process, navigating it will take time.

This means all 23andMe customers who purchased on or after November 22, 2013, still do not have access to health results, nor will they in the immediate future. We are working with the FDA so that we can return a subset of health reports, but we don’t know how long that process might take. We do not have a timeline as to which health reports might be available in the future or when they might be available.

For now, new customers have access to their ancestry results and their uninterpreted genetic data. Customers who purchase 23andMe now should do so with the understanding that health results are not available to them. Again, we do not yet have a timeline for when they may be available.   We are doing everything we can to work through this process and return to providing all 23andMe customers access to genetic health information.

In that effort, 23andMe scientists and executives have met and communicated directly with FDA officials on a number of different occasions over the last few months.  Getting this right is important for everyone involved.

We will continue to be as transparent about the process as we can, and give updates when appropriate.

We remain disappointed that we can not provide you, our customers, with health reports at this time but we remain committed to our mission of empowering individuals with their genetic information.






  • rolandrott

    It´s understandable that this take some time to align with FDA. How about providing health reports for the non-USA national which by definition dont fall under the regulatory scope of FDA? Continuing to broaden the international participation should also be benefical to the overall diversity of data for research as well as ancestry purposes…

  • Sheri M

    Is there something we can/should be doing to help expedite the process with the FDA? Writing / emailing / telephoning campaign?

    • Scott23H

      Sheri,
      We appreciate the support, but at the moment we’re making any recommendations about how customers could lobby or write to the FDA.

  • Siao Jer

    what can one do to help your process? Any sort of petition or something we can do to reach our congressperson?

  • Scott23H

    JoaoC,
    At the moment we are not distinguishing between US and International customers, but we may revisit that policy in the future.

    • kangsongdaeguk

      Please revisit that policy soon.

    • Bond

      yes, please

  • Scott23H

    Thanks for the note, but I think it’d be crazy to ignore the FDA. We’re taking a more prudent path and working with the agency so that we can quickly get back to offering health results to new customers.

  • Wilma Flintstone

    Do you have access to Promethease on Demand. If so you can download your raw data.

  • phairphair

    @International customers:

    The FDA isn’t concerned with the location of the end consumer, just the processes of the corporation and if they are regulatory compliant.

    For example, the FDA wouldn’t allow a food production plant to circumvent safe food production practices just because the product is being exported and not consumed domestically.

    I’m sure it’s the same with government agencies in your own countries (such as they are)… right or wrong, it’s best not to antagonize them with the appearance of anything less than 100% cooperation.

  • Scott23H

    At the moment we are not distinguishing between international and domestic customers.

  • Chuck Hallback

    Bought a kit before Nov 2013, I think. How do I confirm the date? What’s the refund policy? Thanks.

  • Scott23H

    Beth,
    The post in March is an update of where things stand at the moment. We really don’t have the ability to tell you how long this will take. It’s not a single submission. It will be a series of submissions, that will likely include feedback from the FDA that we will have to respond to. We will continue to update people along the way.

  • KeithM

    Hopefully this is the correct place to ask this question. I am interested on what exactly is meant by the uninterpreted raw genetic data that we get back.

    I am a geneticist and can do my own analyses so I am interested in the data format and what information is provided about each assay. Which marker types are you using? Do we get sequence data back (i.e. is it BLASTable) or is it some other marker type (e.g. single nucleotide polymorphism or microsatellites)? If the data is in variant call format, are publicly available locus names attached to the variant calls or are they designated by unintelligible in-house assay names?

    For the record: I, for one, think the whole deal with the FDA is a rather ridiculous, as you weren’t ever providing medical advice. I heard about the whole deal while attending the Plant and Animal Genome Conference back in January. Sorry you guys got stuck dealing with all this.

    • Scott23H

      Hi,
      Yes you can download a file that contains all the calls for all the SNPs that we tested. The raw data is downloaded as a zipped text delimited file and it includes all the genotype call data (your A’s, T’s, C’s and G’s) for each SNP tested.
      It can be opened in a text editor like WordPad. The download feature requires you to re-enter your account password as well as enter your answer to the secret question that you chose during account setup.

      • KeithM

        Hi Scott,
        Thanks for the reply. How are the SNP assays designated? i.e. what are the locus names? Are they something that would be publicly available somewhere? i.e. Are the loci available on NCBI? I’m particularly interested in the PKU assays. My son has PKU, my wife and I are both carriers. We have a daughter who does not have PKU. We are also interested in tracing our mutations back through our parents and siblings.
        Thanks,

        • Scott23H

          We typically assign rs numbers. There is some explanation of assignments here (https://customercare.23andme.com/entries/21272593-which-dna-strand-does-23andme-report-for-snp-genotypes). We have a custom chip and we don’t publish what is on the chip, but you can download all of your data with each of the SNPs listed. We don’t presently report health information back to customers, but in the past we had a report that specifically looked at PKU. Our chip does include some of the variants in the PAH gene.

  • Gus

    Dear 23andme,

    can I send in new samples under the existing account and get the health report for those (eg for my son) ?

    • Scott23H

      Gus,
      You can’t send another person’s sample to be tested for your account. And no, we can’t give health results to customers who purchased after November 22nd, 2013.

  • Scott23H

    Keith,
    There are plenty of people who’ve been able to use their raw data. It’s not meaningless. And no we don’t give out the SNPs that are covered on our custom chip, but if you’d like to see what form the raw data comes in you could probably look through snpedia and see some examples. In addition there are individuals who’ve posted their raw data on GitHub. Remember there are different versions of the chip. We currently are using v4.
    Here is an example of the first lines of data that you would get if you download the raw data:

    “Below is a text version of your data. Fields are TAB-separated
    Each line corresponds to a single SNP. For each SNP, we provide its identifier (an rsid or an internal id), its location on the reference human genome, and the genotype call oriented with respect to the plus strand on the human reference sequence. We are using reference human assembly build 36. Note that it is possible that data downloaded at different times may be different due to ongoing improvements
    in our ability to call genotypes. More information about these changes can be found at:
    https://www.23andme.com/you/download/revisions/
    #
    More information on reference human assembly build 36:
    http://www.ncbi.nlm.nih.gov/projects/mapview/map_search.cgi?taxid=9606&build=36

    # rsid chromosome position genotype
    rs4477212 1 72017 AA
    rs3094315 1 742429 AA
    rs3131972 1 742584 GG
    rs12124819 1 766409 GG
    rs11240777 1 788822 GG
    rs6681049 1 789870 CC
    rs4970383 1 828418 CC
    rs4475691 1 836671 CC
    rs7537756 1 844113 AA
    rs13302982 1 851671 GG
    rs1110052 1 863421 TT

    • KeithM

      Hi Scott,

      Perfect! You provide the location (Chromosome and position) of each locus on the reference genome. That is what makes it very meaningful and likely just scored you several customers. I only meant it would be meaningless if all that was provided was the rs number and the genotype. e.g. rs1 AA; rs2 GG, etc.

      Thanks!
      -Keith

  • Dana

    Technically, you’re still getting the results. What you are not getting is someone’s interpretation of the results for you so that you understand what you’re seeing.

    Whatever the FDA decides, as long as 23andMe still provides the raw data, what I’m going to do when I get around to ordering is looking up basic info on the genes that interest me and then looking to see what my personal results are for those genes on the raw data when it comes back.

    I don’t need the FDA to hold my hand for that. I already know genes are only part of the story. I mean, take breast cancer genes for example–MOST women who get BC did not have any special genes for susceptibility. The vast, vast majority of cases are environmental or lifestyle-based. And for some other genetic situations, like the MTHFR mutation–with that one, you just avoid folic acid and supplement with methyl folate and maybe take a few other precautions. If you don’t have an obvious genetic disease, in which case you probably already know you have it, it’s all a matter of being sensible and playing the numbers a bit.

    What I will never understand is that the FDA said, “if a customer gets upset at their genetic test results, they’ll go get a drastic procedure done,” but if that is even possible, why isn’t the FDA coming down on *doctors* for encouraging patients in this foolishness rather than insisting on followup testing? I should think that’s where the actual problem lies. Call me crazy, I guess.

  • Alfonso Vergara

    Does 23andme get to keep your DNA, then sell back the information they gathered to you and potential buyers?

    • Scott23H

      Some customers can ask to “biobank” their samples, but it’s up to them. The rationale for doing this is so that if we develop a new chip we can then rerun their sample on this new technology so that the customer does not have to submit a new sample. We do not “sell back” information to customers. We give customers access to their full raw genetic information, which they can download at any time. We also do not share individual data. We take privacy very seriously and have a number of safeguards to protect our customers information. You can go here for more information: https://customercare.23andme.com/entries/21252153-How-is-my-personal-information-protected-

  • Serra

    I did 23andme for fun and to investigate my family ancestry.
    For Christmas 2012, I gave my husband a kit as well. It was all fun, until his
    results came back with the same genetic mutation for Hemochromatosis. We were
    both carries, meaning we could have passed a double mutation to our 3
    boys. Hemochromatosis is a genetic disease
    where the body cannot get rid of excess iron and can cause iron overload. There
    are no warning signs for iron overload and the symptoms only show once damage is
    done. The iron can collect in the brain, liver or other organs causing organ
    damage and failure. As soon as this we
    knew about the possibility of my children having Hemochromatosis, I called my
    family doctor, who sent the boys for blood tests. All 3 had high iron levels
    and we were referred to a geneticist.
    The geneticist looked at my husband and my 23andme profiles and said we
    were lucky to find this information. He educated me on Hemochromatosis and
    requested genetic testing for my sons. In
    the end, one of my sons DOES have both mutated genes for Hemochromatosis. We
    are so thankful to be aware of this! We can now monitor his iron levels to
    prevent damage later in life. By the FDA
    taking away the Health Information available on 23andme it is preventing other
    families from finding genetic information that could save lives!

  • Scott23H

    Specifically the FDA is regulating 23andMe’s product as a medical device. So were are submitting material as part of what they call a 510k. That will include detailed studies related to many things including our genotyping chip and the information in our health reports.

  • Scott23H

    Jbird,
    We can’t speculate on the timing or outcome of the regulatory review process, but are committed to working with the FDA.
    We will let our customers know where we are in the process as it evolves.

  • Scott23H

    Thanks Sheri, I made that edit.

  • Neoliberal Agenda

    Can’t you move the company to a country where they don’t have these stupid laws?

    I have a hard time seeing US government banning web sites or forbid people to send their spit abroad. If you don’t move the company, other services will, and then they will get you cutsomers.

  • Nick C.

    This looks really interesting. A 20 + minute video on how it works is fascinating. FYI, it costs $5. to have everything analyzed.

  • http://MakeWP.com/ Thomas Howard

    What country can I fly to in order to get the health report?

  • http://www.joshuascottmccullough.com/ Josh McCullough

    This is so ridiculous. Get the government out of our way! Now they can tell us what we can and can’t know about our genetic makeup? How dare they! This is disgusting. (Thank you 23andme for trying to work through the issue.)

  • http://www.joshuascottmccullough.com/ Josh McCullough

    Idiotic US laws affecting non-US citizens! That is super lame. Sorry about that.

  • Fandroid

    I read this eagerly, as the title said there was an update. Alas, no update. Nothing new, nothing to elaborate on, nothing to see here, folks.

  • http://www.PostPeakLiving.com aangel

    Oh, sure. A young company should get into a fight with a major regulatory agency. Brilliant advice.

  • mahlersGhost

    Once everything is cleared up with the FDA, will customers whose health interpretations were previously unavailable then have access to them? Or will they be required to purchase another kit?

    Thanks and apologies if this has already been answered–searched through but couldn’t find an answer. :)

    • Scott23H

      MahlersGhost,
      We don’t know when or if we will get FDA clearance, but if we current customers will get access to the health information we are permitted to report at no extra charge. But, although we are hopeful about this process, we don’t know the outcome.

  • Kimberly Tidwell-Mashburn

    I wish to God I could be a part of a clinical trial and get some relief :(

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