23andMe at FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs)

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.

Ashley Gould of 23andMe at FDA Public Meeting on LDTs, July 20, 2010

Transcript 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.