Press release
July 27, 2010 Foster City, CA
Navigenics Statement
Last week federal officials convened a series of meetings and hearings in the Washington D.C. area to discuss the prospects for personal genomics services and other innovative types of health-related tests. We were pleased that the need for industry standards was acknowledged at a high level during a two-day meeting hosted by the Food and Drug Administration. Given its inclusiveness, broad discussion, and scientific rigor, the FDA meeting reflected the type of approach and expertise that will be required to develop effective standards for personal genomics.
On Capitol Hill, a subcommittee of the House of Representatives’ Committee on Energy and Commerce held a hearing on “Direct-To-Consumer Genetic Testing and the Consequences to the Public Health.” Our CEO testified at the hearing and we filed thousands of pages of informational documents with the committee before the hearing. A key part of this hearing was a report by the Government Accountability Office, or GAO, on 15 personal genetic testing companies. Even though the report was not designed as a “rigorous, scientific study,” it did bring forth a key issue for our industry: the need for industry standards. Navigenics has been focused on this need since the company’s inception and believes that we now have the momentum we need to work with others in our field toward a shared goal of strong standards. Navigenics has consistently been – and will continue to be – a leader in encouraging collaboration and dialogue with regulatory authorities to ensure compliance and develop standards for the industry’s technologies and services.
It is well known that the current lack of regulatory standards can lead to very different approaches between personal genetics companies. At Navigenics, we have chosen an exceptionally conservative approach based on stringent scientifically criteria, and our company standards and practices have won us the partnerships of leading health care institutions across the world. We remain the only personal genomics company that is approved to operate in all 50 states, and provide our services through physicians and corporate wellness programs.
Our discussions with the FDA began even before our service first launched, and we most recently met with FDA officials in May of this year. In fact, the company has an established history of working proactively with state and federal regulators. When Navigenics launched its personal genome service more two years ago, we issued a 10-point proposal for a set of industry standards to ensure the integrity of this new field of science and health and safeguard consumers. We highlighted the need for these principles again early last year when we helped the Personalized Medicine Coalition convene a meeting on standards for personal genomics services.
Navigenics remains committed to delivering the highest quality genetic information to consumers and their health care providers, and to providing resources that will enable the use of that information to help direct personalized health strategies. We applaud the leadership of the FDA, along with other federal officials, as they make productive steps towards a new framework for our industry.
As plans for regulation unfold, we stand by our science, our service, and the standards we first proposed in 2008. We are meeting with FDA next month to delve into more detail on a cooperative regulatory framework going forward.