Update On The Regulatory Review Process With The FDA

By Kathy Hibbs, Chief Legal and Regulatory Officer, 23andMe

A few days ago the US Food and Drug Administration accepted for review 23andMe’s submission for a new 510 (k) application. This submission is for one health report, and 23andMe_Logo_blogis part of the FDA’s regulatory review of our health product.

Although the submission focuses on a single rare but serious inherited condition we report to customers – Bloom syndrome – it is an important step in our work with the FDA in the coming months. Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions.

More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them. The submission includes robust validation data covering major components of our product such as the genotyping chip, software and saliva kit.

While we are still in the very early stages of this regulatory review process, we remain committed to transparency and keeping our customers as informed as possible. This by no means is the end of the process even for this one condition. It is likely that 23andMe will hear back from the FDA regarding the material we gave to them, and, we in turn will have to respond to those questions as we move forward.

We are pleased to be moving forward with the FDA and committed to our company mission of empowering individuals with their genetic information.

If you would like to know more about the 510 (k) process, you can read more on the FDA’s website.

  • EroSennin

    I was going to use 23andMe’s services earlier this year until I heard there was no health related information. After reading up on the privacy policy and generally getting more educated about genetic information, I feel pretty good about it. They don’t share my information with insurance companies.

    I guess I still have a question: If I buy the services now, will I get the health data once it opens back up & the FDA approves it?

    • Scott23H

      We don’t know what the outcome of this regulatory process will be but we hope to offer health results to customers in the future.

      • cookiersmom

        Your answer is unclear. When (if) 23andMe gets approval, will customers who have had their testing done during this interim period automatically get their health report added to their 23andMe page?

        • Scott23H

          Yes, customers who have tested in this interim period will get access to health reports for which we’ve received agency clearance, but again, although we are hopeful about the process, we do not know when that might be or what, if any, set of health reports will ultimately get cleared.

    • RandyZie

      there are third party websites you can upload your 23andme data to. So even if they don’t enable health data, you still have that data to bring to other websites.

  • JLMarsino

    I really hope the genetic information is offered soon. Please keep it up 23andMe! I am waiting patiently!

  • Felecia Cornelius

    Ero – you can submit your report from 23andme to https://promethease.com/ondemandagreed for your health report. It cost $5 and results takes approximately 5 minutes after submission.

  • Scott23H

    Yes, we will have to get FDA clearance for each of the reports.

    • John L.

      How about making sure your reports are based on accurate information and using SNPs known to cause a condition. Many of them rely on a very small percentage of SNPs relative to how many known SNPs affect a particular condition that 23andme’s information is so far off-base to be dangerous. Worse, your lung cancer results would either scare a person into thinking they are going to get lung cancer or convince a high-risk smoker they aren’t going to get lung cancer to be not only dangerous, but almost criminal. Do away with the percentages in the first screen if they aren’t based on solid information. Better for 23andme to show us what conditions are caused by what SNPs, if 23andme tested those SNPs, and what our results are (more or less likely, or average odds), plus the known environmental factors that can greatly increase or decrease our risk factor.

  • Fahim Uddin

    If I buy the kit, do I have to pay for monthly online membership fee or is it given to me for lifetime?

    • Scott23H

      There is no monthly fee. It’s a single price of $99 and that gives you access to your account. You can download all your raw data as well.

  • WilliamShipley

    It seems that there is a fundamental disconnect between the level of certainty that the FDA expects for a diagnostic test and the incomplete information that me and many other 23 and me customers are interested in perusing.

    One of my SNP’s indicated a slight increase in the liklihood of a condition and looking at the studies showed that they were far from reaching a definitive consensus. It seems likely that there were other factors that were influencing the output.

    I doubt that with such uncertain background you could get that approved but the information is still interesting and useful. There must be some way of distinguishing between results that are sufficiently verified to be considered a laboratory test and those that are still open to interpretation.

  • Jamie

    I read Dr. Jeffrey Shuren’s posting on FDA Voice concerning the accuracy of genetic testing. I’m glad they appear to agree that having access to your own genetic information is valuable.

    The health reports saved many many lives. I know this from reading those who chose to share their stories on 23andme blogs. There are countless others who benefitted as well. 23andme clearly stated on the health reports that they were meant to be data points to be factored in, not end-all-be-all jump off a cliff type of pronouncements.

    No information is 100%. Even your basic strep throat test (and any other test) has false negatives and false positives. No one can expect 23andme to provide 100% certainty. Nothing does. Adding information and facts is the best way to get a complete picture.

    Americans should have the right to choose to access imperfect information, just as they do every day in any medical situation.

    If the Bloom Syndrome submission is successful, please submit the other 310 or so health pieces in parallel so that we can get this thing back on track as soon as possible.

  • Teleny

    The FDA has no jurisdiction outside the USA, surely. So what’s to stop you providing genetic health info to non-US citizens – right now ? btw, in my view the health info you gave me was 100% accurate & responsible (I’m a medical journalist). It’s clear FDA’s hidden agenda is to maintain the health monopoly of their friends in the drug companies and the medical establishment in general.

    • John L.

      Far from it. My health reports were so full of holes, misinformation, and misleading information the FDA was fully justified in their actions. If anything, people defending 23andme are the ones who should be questioning why 23andme ignored the FDA for so long.

      • Nick Bauer

        What holes? What misinformation? What misleading information? Some examples would be nice.

      • bdnb

        There’s nothing about the reports I got from 23andme that proved to be misleading. I was impressed with the wealth of information, which confirmed some suspicions I had. Personally, I don’t see how these genetic tests are used for the purpose of treating diseases. Could this information even be considered a medical diagnosis, as per the FDA letter? I would think a medical diagnosis would involve more than just a some data extrapolated from a database to provide percentages based on genetic markers. If I wanted a full medical diagnosis, I’d consult a doctor who could place raw data in a broader more informative context. But this is just information that could prompt a real diagnosis from a doctor. This whole case really comes down to what’s a “diagnosis.” Without that word in the code, there’s no justification to prevent access to such reports.

    • Nick Bauer

      They are a US company. And for whatever reason, 23andMe did drop the ball on approval–it isn’t the FDA’s fault.

    • Joshua Spatz

      The FDA dates to an era of significant information asymmetry – people had little power to verify the claims made by drug companies, and so agitated for a political solution to their risk exposure in the form of a powerful regulatory agency.

      Of course, the days of information asymmetry are long gone; the internet has made just about everything anyone says in any context searchable, referenceable, and verifiable. 23andMe is part of that: they’re providing information in a methodical and accessible way.

      That’s why I think this is far more insidious than the FDA just attempting to maintain the power of vested interests in the medical establishment: exerting control over the dissemination of information is pretty much the only thing the FDA can do to stay relevant and maintain its own power.

      They have a built-in incentive to shut down or distort independent sources of health-related information; if they do nothing, the public at large will gradually realize that they have the ability to make informed health choices on their own with the same level of risk mitigation, without having to cede the right to make health choices to the FDA.

      I think we can ultimately expect much more of this from the FDA, unless people start standing up to them and taking their threats to litigation every time they’re made.

    • Chris Bartlett

      Hi Teleny, another medical journalist here and I also can’t understand why the FDA has any jurisdiction on reports for non US customers. I also think their agenda is to maintain the (immensely expensive, especially in the US) monopoly medical professionals have on health as well as to try and limit overall healthcare expenditure by ensuring that many patients remain ignorant of conditions they may be suffering from or are liable to suffer from in future. There is a profit motive too, why let people check all their genes for 100 USD when you can charge thousands of dollars for each individual genetic test as well as pad the bill with expensive medical consultations and counselling?

  • John Marrone

    Here is an original complaint made to the FDA about 23 and Me:


    – it states:
    “My pt had not been offered brca1/2 testing

    because she was unaffected and did not meet our clinic’s criteria. She saw that
    included in 23 and me’s test menu was brca1/2. What she did not know is that 23
    and me only tests for the 3 founder mutations, and my pt does not have any
    ancestry, making this test a waste of money for her, as she was not interested
    in any of the other info provided and stated that the other data only served to
    increase her anxiety level about her health.”

    Just bringing this to the attention of all those here so all are informed. Cheers – JM.

    • Nick Bauer

      People should realize, and there are plenty of warnings on the 23AndMe pages, that these results do not take the place of a clinical test. WebMD’s symptom checker and many other sites should be taken down if the bar is just giving out information that makes people anxious about their health.

  • BobG

    I wish 23andme would be more aggressive in fighting the FDA, their policy is a clear violation of the 1st amendment, they are trying to abridge speech, no treatment is involved. I understand you’re running a business but you do your customers and ultimately your company a disservice by trying to “play ball” with the FDA rather than challenging them

  • Jenavive

    I am glad to see 23andme working with the FDA to empower individuals with information about their health in a cost-effective way. I was sorely disappointed when the FDA got involved in the first place, but if it can be resolved I think that’s a wonderful thing.

  • chamel77

    As a Canadian citizen who has used your service, can the FDA prevent me from obtaining that information from you? Does the FDA have any jurisdiction over my genetic information?

  • Seth Bittker

    It seems to me that I should own my own genetic data and having access to it can be valuable in understanding medical vulnerabilities. So by providing me with access to my genetic data along with related medical citations, 23andme is doing a great service and is doing no harm to anyone. Conversely by interfering in this process, the FDA is doing great harm.

    Two questions:

    1) What specific clauses in the law allows the FDA to restrict the data that 23andme can provide to me on my own genetics?

    2) Assuming there are such clauses, are there any people or groups that are attempting to get the law changed?

    • Scott23H

      I can’t answer your questions directly, but I can say that the FDA is regulating us based on their judgement that our product is a medical device as opposed to just genetic information.

  • Jane Shealy

    This is ridiculous. Why would you start with a report on some condition the majority of your clients won’t have? And, only one report. This whole situation has been very badly handled. The company, not the consumer, should be punished. The FDA has no business telling anyone whom they can ask for an interpretation of genetic data.

    • Scott23H

      We will submit on other conditions but this one helps with giving us the parameters of what the agency wants from us. We’ve already gotten feedback from the agency and all of that, we believe, will help as we make submissions on other conditions.

  • Ashley R

    Can we move this along a little by using the broadly networked petitioning tools of change.org or moveon.org or the like?

    If so, we need someone eloquent and well imformed to start the petitons to get the masses interested. I havent seen such a petition yet but would very much like to.

    I was lucky enough to use 23andme before the FDA imposed the change. I found out I have a stronger risk for an intherited condition than previously estimated, which stinks but with a handful of anxiety disorders I still managed to process that information well. Now I know when I scold myself if I dont eat enough veggies known to reduce risk its not for nothing. I worried about all this stuff for years before anyways – the report actually releived anxiety as instead of being overly worried about every unpleasant condition out there, I feel like I can relax my worry about some stuff because many things have low odds. In summary – I would be a prime example of a person who they would worry couldnt handle the info recieved and if anything it helped me realize even if some bad things happen, I dont really need to spend my entire life worrying about every condition under the sun.

    Hmm. Politics. The FDA is so particular about this but they are not so particular about the way some drug information is presented. On NPR I had just read an article yesterday which brilliantly depicted a simplistic representation (published in an image) of a major advertised drug so people and doctors can better decide if worth prescribing/taking.
    For those interested in bettering the information availible to consumers and even doctors, look up informulary.
    I feel silly specifying but just incase: I am in no way affiliated with any of these groups. I simply want my doctors, myself, and society to have better information so we can together make better choices.

    • humpfh

      There were several petitions, including one on the White House website, posted when the initial ruling was made.

      I agree the FDA way overstepped here. NOTHING IN THE WORLD ever can or ever will belong to me so completely and individually as my own DNA.

  • metawatch

    Are you contemplating releasing Health Data for Canadian residents ? I am one of the customers who purchased your product while health reports were still part of the package but seemingly to late to receive the heath reports none the less. I as a result I used the https://promethease.com/ondemandlicense (Promethease analysis) as a temporary stop gap measure to obtain a summary based on SNPedia data comparisons. It’s great insightful data, but would prefer to have a more formal report from 23andMe. It really doesn’t make any sense that promethease can release a report on (using) 23andMe data (SNPs) but 23andMe can not….. Especially since there doesn’t seem to be any regulatory agency preventing its release to Canadians

    • Scott23H

      At the moment we are not distinguishing international customers from domestic US customers.

      • metawatch

        Thank you Scott ! The question was if you were contemplating (Forward Looking) looking at publishing health reports for international customers independently, of the current FDA limitations on the publishing of Health reports for domestic US customers ?

        • Scott23H

          I wish I could be more direct in answering your questions but I can’t. All I can say is at the moment we are not distinguishing between domestic US and international customers.

          • metawatch

            Thank you, you answered my question….

  • Keeks

    Is there any reason my reort cannot be sent to my Primary Care Provider, who can then share ir with me?

    • Scott23H

      What you are suggesting is one idea that has floated around, but that is not what we do currently. In other words we are still working with the FDA so that we can allow customers to get their genetic health information directly without having to go to a physician to get access to that information.

  • Masha

    Can anyone please answer my question? – I have three kits for my kids and myself but i haven’t submitted them yet. With all the publicity 23andme were recently getting, is it still OK to send them back the kits and will i receive our reports back? thanks

    • Scott23H

      You will still get your ancestry results and you can also get access to your raw genetic information. What you won’t get right now is your health information.
      If you have other questions about the kits you purchased please contact our customer care team here:https://customercare.23andme.com/anonymous_requests/new?reference=via_sidebar

      • Masha

        Thank you Scott, I collected the samples and sent them out this morning. How long does it take to get the information and will i be notified that it is ready, or do i have to check at some point. I am interested in all 3 results and two of them are for my children…. thank you!

        • Scott23H

          It may be six to eight weeks. You can track the progress of your sample. You should get an email notification when the sample reaches the lab and once it is processed. You will also get a notification once your results are in.

          • Masha

            Thank you so much Scott for the information. I’ll be looking forward to receiving these updates and then for the final results.

  • Massimo Concas

    Will the health reports released before the FDA shenanigans and still available for the lucky customers who got in in time, like me, be retroactively affected by the progress on aforementioned shenanigans?

    • Scott23H

      If you currently have access to your health reports that won’t change. What will change are health reports going forward, but again that depends on this process with the FDA.

      • Massimo Concas

        Thank you

  • Scott23H

    Because we don’t know what reports will or will not get cleared by the FDA this is a hard question to answer. I can say that we hope to give customers the same opportunity to share health information as they have had in the past.

  • Joshua Spatz

    I’m really disappointed that 23andMe has decided to yield to the FDA’s unconscionable and unconstitutional demands that it be allowed to act as a gatekeeper for individuals’ access to information about their own genetics.

    23andMe should have immediately litigated against the FDA’s ultimatum, so that the agency would have at least been subject to judicial scrutiny, and forced to explain what they believe to be the statutory and constitutional sources of their claimed authority to regulate a purely informational product. I’d hope and expect that the courts would find that no such authority exists, and leave this nascent industry free to serve its customers without interference.

    Hopefully, one of 23andMe’s competitors will find a lucrative opportunity in litigating the issue, and hopefully 23andMe and their investors will discover that the costs they’ve incurred in the form of compliance expenses and loss of customer goodwill were all a tremendous waste.

  • bdnb

    It’s not clear how I’m not entitled to information about my genetic code and predisposition to health issues. Can only certain corporate interests and governmental entities access such information? I don’t see how the FDA can justify this? I’m sure this is to protect special interests who want to be more guarded with our personal information and charge a lot more for it. But what’s the precise justification, and is it a sound justification under the Constitution? Is there anything in the Constitution to support the idea that personal information about our genetic code is best left to certain experts and not to us? Does the need for “protecting” the public overcome our rights to personal information about ourselves so we can make our own informed decisions and seek out medical advice?

  • 23blog

    We don’t know the answer to your first question, and since we having completed the process I don’t know how fast or slow the process will be.

  • jesskazen

    I found out that I’m a carrier for Hereditary Hemochromatosis – the disease that most likely killed my father 18 years ago at the age of 46 years old from unexplained cirrhosis of the liver via my 23andMe DNA test. I needlessly lost my father at 13 years old because there was no test for HH or knowledge in the medical community about how prevalent it is and how easy it is to detect by DNA test. The Genome wasn’t even mapped back then.

    No doctor has ever in my life tested me to see if I had this disease or was a carrier. I found out because of 23andMe.

    We have a wealth of lifesaving information and any barriers to gathering this information is a direct threat to our right to life, liberty, and the pursuit of happiness.

    With this knowledge I could save my future children’s lives.

    The FDA has no place in preventing people from testing their own DNA. My DNA belongs to me!

  • Tracie Boyle

    I wish they would be as strict with food labeling as they are with 23andMe. There are so many things that are considered “safe” in the US that are banned in other countries.

  • 23blog

    Hi Humpfh,
    We hope to have san update in the very near future.