23andMe Presents at FDA Advisory Panel Meeting on Direct-to-Consumer Genetic Tests

Editor’s note: This post has been altered from the original. The slides from the presentation have been removed. 23andMe, like many others, believes that individuals have a right to access their own genetic information and that personal genetics will pave the way for significant advances in healthcare. These beliefs fueled the development of our direct access Personal Genome Service ®  and 23andWe, our web-based, participant-driven research platform. As for any other new industry

or technology, however, there are concerns about the validity, accuracy, and applicability of the services and information that companies in the direct-to-consumer genetic testing industry provide. 23andMe supports thoughtful regulation that ensures consumers receive high quality information and enables, rather than inhibits, innovation. Over the next two days, the FDA is hosting an Advisory Panel Meeting to address a number of questions related to clinical genetic tests that are marketed and provided directly to consumers. The FDA will be hearing the ideas and perspectives primarily of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, which include voting members and temporary members added for this meeting. In addition, the FDA has invited several speakers to present background information and their views on this topic, and has provided for one hour each day for public comment. It is during the public comment period that 23andMe will be giving two presentations. This afternoon, 23andMe’s General Counsel Ashley Gould will speak about our position on the subject matter the panel will be addressing as well as our broad requests for the panel’s consideration. 23andMe’s Senior Director of Regulatory Affairs & Quality Assurance, Rose Romeo, will present tomorrow afternoon on considerations for risk mitigation and thoughts on regulatory frameworks moving forward. Slides from both of their presentations can be viewed below. The agenda and other background material are available at the FDA website, including public comments. Much of the complexity in discussing regulation of genetic testing stems from the brisk evolution of technologies in this area. The first draft sequence of the human genome was first published only 10 years ago, and companies are now sequencing full genomes on demand at increasingly affordable prices. In our presentations, we take the position that all genetic testing services, whether ordered by a physician or offered through direct access, should adhere to the same standards. We simultaneously request that the FDA consider redefining and establishing regulatory standards, including some fundamental definitions, to accommodate large-scale genetic testing and support innovation of its technologies and applications. We also request that regulation be based upon evidence and not fear of potential harm to individuals which, to date, has not been demonstrated. In fact, growing numbers of participating individuals and independent studies focused on this issue provide preliminary evidence that the vast majority of people understand the information presented and experience no significant negative effects. 23andMe has been proactively collaborating with the FDA and remains committed to finding a path forward that benefits everyone. The addition of Rose Romeo to our team, who has extensive regulatory experience and is eager to help us forge that path, attests to the strength of that commitment. We look forward to working together with a wide variety of agencies, organizations, and the medical community at large to establish the regulatory and functional frameworks that will ensure consumers and healthcare professionals have access to genetic information that is clear, useful, and engaging.
  • Maureen Markov

    Great effort, best of luck!

  • Thanks for sharing your presentations and keeping consumers informed on this issue. Everything I have experienced in my work with victims of a genetic condition (hereditary hemochromatosis) leads me to think you are taking the right position on the issues that the FDA is considering.


  • Irina I

    I love what you guys are doing, both as a customer and a general consumer. First, you are affecting people’s lives by helping them in making lifestyle choices that will positively affect their health (by providing information about disease risk). Second, you are part of the solution of the huge problem of escalating health care costs in the United States. By giving consumers information about their disease risk, you give us a chance to prevent it and not end up in the emergency room.

    Keep up the great work!

  • Fred

    What you are doing with DNA could be revolutionary to the future of healthcare and it’s too bad that some of your tests may have to go through bureaucratic channels (dr’s offices etc) in the future.

    Regulation is great in weeding out scam artists but at what cost? Jeapordizing Innovation? The average genetic counselor at your company can explain results much better than most doctors. A lot of people who use your tests use them as one of many tools to help promote better health and will not use your results alone to evaluate and make major decisions regarding their health….. Most of us simply want to be part of of this new innovative approach to healthcare and pay the price for the tests in the same sense as making a donation to science….. Test results are just a fun bonus… if that makes any sense. If these tests become required thru a doctor, perhaps we could see 23andme dr’s offices in a city near me or virtual dr’s online like you see in those tv commercials Haha I can guarantee you my dr office does not have a geneticist on board!

  • Fred

    I forgot to to add that irina’s point about prevention is very important in my opinion as well…… With the new healthcare bill, you’d think prevention would be key focus point for the FDA and insurance companies alike in helping reduce overall healthcare costs…. I hope that the FDA would consider the potential of your tests for promoting awareness and prevention for consumers, especially that consumers are willing to spend out of their pockets for the tests…. Potentially saving gov. healthcare boatloads of money in the longterm.

  • Shirley Grose

    My family and I fully support 23andme in their goals that include giving individuals their data at an affordable price and in an understandable format, and the freedom to decide what to do with it when they read it, whether they are genealogists or medical consumers, or the curious. I resent the FDA panel’s decision that a consumer should go through a doctor for their genome test. I own my genome. I want to know what genes influence my body, now, and those to come in the future. Thank you 23andme for one of the most educational, exciting experiences of my life: seeing my genome on the screen.

  • Vovix

    “People have no need to read the Bible by themselves, so that Gutenberg’s device is a stupid and dangerous toy.” (An unknown Catholic priest, 1511 A. D.)

  • Mojo

    What are the possible “dangers” of individuals dealing directly with the people who are providing the genetic info? I’m usually not so cynical, but this sounds like an early attempt at making sure as much money as possible is funneled through AMA channels. Obviously if I have to go through my doctor to order a test like this, it’s going to cost a whole lot more. This defeats the whole point of companies like TTAM striving to make these tests affordable to the average consumer.

  • Robert

    This may be all well and good, but to me it’s like going to Lowes to get materials to build Nasa spacecraft. There are so many questions about this, (dangers) it defies the imagination and I can only imagine what kind of person would be thrilled seeing his genome.