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.

    • 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.

  • 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.

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