Personal genomics is an emerging field, and we were aware, when we first started the company, that we would challenge some of the existing precepts about how, and why, people might choose to access their genetic information.
When we launched the 23andMe Personal Genome Service, last November, it was not intended as a “genetic test” per se; it was designed to be a means for people to tap into their own DNA and gain an intimate understanding of the genetic associations researchers are discovering at an ever increasing rate. By providing people the voluntary opportunity to learn more about their own genes, we set out to facilitate genetics going ‘mainstream’, which we believe could hasten the path to personalized health care.
We weren’t surprised to see California and New York stepping in to exert regulatory oversight of this nascent industry. We strongly believe in transparency in the services and information we provide to our customers, and even though we don’t agree existing statutes are the best fit, we agreed to voluntarily apply for clinical licensure from California.
We were happy to work with the state’s Department of Public Health in showing how our scientists validate the genetic markers that are the basis for the health-related topics found in our Gene Journal (now called Health and Traits) section.
23andMe was granted a license on August 15th, which clears the way for us to continue offering our services in California. In the meantime, we’re waiting to hear from New York on guidelines they’ve indicated they’ll propose. It’s clear that this is only the start of the dialogue between regulators and genomics companies that offer direct-to-consumer services. Our hope is that the state and federal agencies will harmonize their efforts so that proper regulation is meted out consistently and with a clear purpose.
Longer term, it’s also evident that new regulations are needed to ensure privacy and freedom of choice to enable individuals to make their own decisions about what is most personal, including access to their own genetic information.