The FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs) took place yesterday and today (July 19 and 20) in Washington, DC. Webcasts of both days will be available from the FDA for the next year.23andMe’s President and Co-Founder Anne Wojcicki spoke about the promise and power of direct-to-consumer genetic testing at the hearing. 23andMe General Counsel Ashley Gould spoke about 23andMe’s educational outreach efforts. Transcripts and slides from both sets of comments are below. (Transcripts adapted from live captioning of the meeting with minimal editing to clarify obvious typos. While these transcripts provide a good overview of what was said, they are very choppy.)
Ashley Gould of 23andMe at FDA Public Meeting on LDTs, July 20, 2010Transcript of Ashley Gould:Thank you.I wanted to point out with all the discussion about the need for a physician intermediary and the discussion on the previous panel that we’ve been involved with two ongoing studies. One with Stanford and one with Johns Hopkins University. And the data will be published soon for those and I think they’ll be very useful to see that people seem to really be understanding the data that they’re collecting through services like ours.So more broadly in terms of education, there’s been a lot of discussion about what FDA will be doing to help route LDTs. And I’m going to focus a little bit more on how individuals can use genetic information and whose responsibility it is to ensure physicians can use this information.Three years ago there were fewer than 300 genome wide studies. Today there are over 2,000 with more published each week. It’s critical for personalized care and we believe education is an important first step towards moving towards integration into clinical care. 23andMe believes education and a greater understanding of genetics across the population both for individuals and physicians alike is critical and part of our mission is to be involved in this effort.As was just discussed earlier we’ve animated four educational videos that are available on our public website, and there have been over 100,000 views of our Genetics 101 video. We think this is a great example of our ability to promote widespread education in a digestible format. We also believe that our personal genome business itself is an important educational tool as learning in the context of your own genetics is powerful.We provide context including describing and vetting established literature. Reports are based on average possible risk, noting the contribution of environmental factors, and providing next steps like talking with your doctor or counselor. We’ve implemented an ability for counselors to talk [to customers] through an independent company.There’s a blog, which is an educational tool. As new research is published and important things occur in the industry, we blog about them and provide timely discussion on these topics in an easy-to-read format.We have a very active and engaged customer community where the customers also discuss topics with each other and engage with 23andMe.We think it’s important that physicians can explore their own genetic data to think about integration into clinical practice. We’ve offered free genotyping to hundreds of physicians as a result. We’ve received important feedback and will continue to seek out additional feedback.We’re also getting involved in medical school programs. There’s been a lot of discussion earlier about the need for physicians to understand genetics better, and we think it’s important to start at the medical school level to talk about genetics and clinical care impact.We also hosted a policy forum last week together with California state senator Alex Padilla, gathering academics, bioethicists, industry and [Inaudible] to discuss important social and ethical issues. I think one of the key findings to note for the day was everybody agreed more empirical data is needed to assess what the risks are, if any, of the kind of testing that we’re providing.We believe we have a powerful opportunity to positively impact public health while providing individuals access to their genetic information. Colleen McBride of NIH has been involved in a number of research projects studying access to the information and published that individuals who help healthcare providers with online genetics information may be one of the most motivated to take steps to higher lifestyles. [Inaudible] so we believe that in order for genetic information to become a routine part of medical care, it will take the participation of individuals, industry, government and the medical community. Physicians will needle point of care tools developed to access as the genetic information grows, both directly to the consumer and in the medical office.And this is happening at a rapid pace. We believe the educational and outreach we’re undertaking is a critical first step to the day integration of genetic information of other laboratory tests will be integrated into clinical care in a comprehensive and meaningful way and we look forward to continuing discussions with the FDA on these important topics.Thank you.