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.)
Transcript of Anne Wojcicki:Thank you for inviting me.Before I go through the whole presentation I wanted to make four points during this time [Inaudible] to this committee and everyone here about why 23andMe was started and principles that are core to our values. First, we are a company of individuals who are passionate about educating individuals about genetics. We update our blog daily and we have over 13,000 regular readers of our blog. Our Genetics 101 video has over 140,000 views on Youtube alone. We also have over 80,000 users who have signed up for demo accounts.Second, we believe there’s a significant uncapped potential for the entire healthcare world to engage consumers in research and in their own health. We believe it’s time that consumers are seen more as partners in health rather than subjects.Third, we passionately believe that information that individuals have the right to get access to their genetic information, 23andMe is committed to working with the FDA to make sure that individuals continue to have that right. Last, we believe the opportunity for preventive medicine is here and now, knowing my genetics profile could be a significant part of helping me prevent disease.We wanted people to be able to learn about scientific research and ancestry through the genetic information we didn’t want to do one area or another but we wanted to have a holistic approach.One of the most important things we’ve learned is that people are discovering information about themselves that they did not already know. It could be that they are carrier for alpha one anti-trypsin or they’re higher risk for a blood clotting event.We started 23andMe with a very holistic approach to genetics.If I look at any of you and I make judgments about your background, I could be making faulty assumptions. Could you be a carrier for sickle cell, could you be a carrier for BRCA 1 and 2? Medicine needs to move from making background assumptions about individuals and embrace molecular medicine.We strive to present information to our customers in an easy to understand format. Based on feedback from our customers and from usability studies we have conducted, we have confidence that customers are understanding how we present the data. We are quick to make changes to the site when we learn that there is any confusion.Our site is updated weekly, and we are constantly trying to improve. A big part of being direct-to-consumer is pointing individuals to external resources to get help or to learn more. We have pages like this throughout our site that point people to their physician or to genetic counselors.A unique and significant part of our site is the research component. If you look at communities like Livestrong and Susan G. Komen there’s clearly a significant interest in individuals to contribute to disease research in a meaningful way. We give individuals that platform for contributing to research.In 2009, we launched our first disease community in Parkinson’s disease. We enrolled over 2,000 individuals in the first three weeks alone. We have over 4,000 participants today. This is a very active community, where over 75% of the participants have taken at least the Parkinson’s survey alone.We hear on a daily basis from customers through our community or through our customer service department that people appreciate the value of the community. We think that the community is a very important part of our site.Last month, we published our first paper based on our community findings. Our goal is to continue to publish our findings as well as to give our customers a sense of pride about the research they have helped create. We are creating electronic badges for customers who have participated and are talking about giving micro attribution to all customers who want to be associated with the paper.We want our customers to feel like research participants and not research subjects.Our research program is set up so that we are running hundreds of genome wide association studies on a nightly basis. We’ve been able to replicate many of the major genetic findings and plan to publish more soon. We think that this database could be extremely helpful for quickly advancing genetic knowledge.Thank you.