Chairman Stupak, Ranking Member Burgess, and Members of the Subcommittee: Good morning, and thank you for inviting 23andMe to testify today. My name is Ashley Gould, and I am the General Counsel of 23andMe. I ask that our full written testimony be submitted for the record.
In the last 10 years, the Human Genome Project has revolutionized genetics. Direct-to-consumer (DTC) genetics leverages these advances by allowing individuals to access their own genetic information. Consumers empowered with this information have made lifestyle changes aimed at reducing their risks of developing disease and have provided information to their doctors to aid in diagnosis and treatment.
23andMe believes the Subcommittee’s hearing today presents an opportunity for all of us to understand the state of the science, to best protect consumers, and to design a sensible regulatory framework for the future. We look forward to working with Congress as well as the FDA and NIH on these issues.
We strongly agree with the Subcommittee that DTC genetic testing must be scientifically valid, accurate, and well explained to consumers. We are entirely confident in our own reports, which we develop in conjunction with our physician and scientific advisors.
We support the Subcommittee and FDA in the effort to create an improved regulatory framework for genetic testing. We are already working with FDA, NIH, and other organizations to strengthen regulations for all laboratory testing, including genetic testing. Indeed, we first met with the FDA in 2007, before we ever offered our service to consumers. Thereafter, in 2008, we met with FDA Commissioner von Eschenbach and his staff, and they encouraged us to proceed. We have had ongoing discussions with FDA since that time.
Tomorrow, we will present our regulatory proposal to the FDA. Our plan takes into account rapid technological innovation and ensures the analytical and clinical validity of all laboratory tests. In addition, we think new regulations should provide transparency across the industry so that consumers know what they are getting from the services they choose. At the heart of any new regulations should be the requirement that DTC genetic companies operate at the highest levels of science and ethics.
23andMe grounds its service in several core elements: informed consent and strong privacy protections; educating customers about personal considerations they should take into account when using our service; educating customers and providing full transparency about the science behind our service; and recommending that, if customers have questions about their results, they should coordinate with their physicians or a genetic counselor. Indeed, we are proud that, in 2008, our company’s DNA-testing service was selected by TIME Magazine as the number one “Invention of the Year.”
One of 23andMe’s core missions is the development of innovative solutions for accelerating genetic research. Our database is one of the largest collections of genetic and health information in existence, and has already led to published discoveries. We are currently working with the Parkinson’s Institute on research aimed at discovering the genetic factors underlying Parkinson’s disease. We are proud to have with us today the head of the Parkinson’s Institute, Dr. William Langston, one of the leading Parkinson’s researchers in America.
We appreciate the concerns that people who receive DTC genetic information could make harmful decisions without consulting a physician, or could be lulled into inaction based on their results. However, we have seen neither data nor scientific literature to support this view. Indeed, the current scientific literature, combined with our own experience, shows that people do not take rash or unconsidered actions.
Moreover, 23andMe’s service is consistent with the FDA’s long history of approving at-home, over-the-counter laboratory tests for HIV, hepatitis, and other diseases, in addition to permitting consumers direct access to tests for other conditions, such as high cholesterol and pregnancy.
We believe the current regulatory landscape is ready for improvement, and we welcome your interest and leadership in this area. Thank you, and I look forward to your questions.