Validity. Accuracy and quality. Clinical relevance. Security and privacy. These were among the top themes highlighted over and over when federal officials convened a series of meetings and hearings last week in the Washington D.C. area to discuss the prospects for personal genomics services and other innovative types of health-related tests.
For long-time readers of this blog, these ideas are nothing new. When Navigenics launched its personal genome service more than 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 reiterated 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.
So when last week’s events kicked off with a two-day meeting called by the U.S. Food and Drug Administration, we were pleased that the need for industry standards has been acknowledged at a high level. At the gathering of experts in health, genetics, science, and the law, many good points were raised and excellent ideas exchanged. Navigenics was among a group of leading personal genetics companies that presented a company overview to the gathering, and our CEO, Vance Vanier, M.D., was the only executive from a personal genomics service given the opportunity to speak on a panel. In 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.
The next day, however, saw a very different – and less productive – atmosphere come to light. 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.” A key part of this hearing was a report by the Government Accountability Office, or GAO, on 15 personal genetic testing companies.
The ultimate aim of the GAO report was to inform and protect consumers. At its best, the report sheds further light on an important and well known issue in the personal genomics field – how the current lack of regulatory standards can lead to very different approaches between personal genetics companies. But as the writers of the report acknowledged, they “did not conduct a rigorous scientific study.” As a result, many of the report’s findings are anecdotal, partially informed, or incomplete.
We would have been happy to work with the authors of the report to answer any questions or provide further information along the way. Our CEO testified at the hearing, and we filed thousands of pages of informational documents with the committee before the hearing. But Navigenics was not permitted to see the report before its release. Nor were our company’s representatives even allowed to see a copy at the hearing itself. As a result, we could not always fully address questions from Congressional representatives during the hearing, and regret not having been given the opportunity to prepare all the answers that were sought.
Furthermore, the report makes assertions that are backed up by incomplete information. We have made a formal request to the GAO for the detailed information behind these assertions. Should that detailed information be forthcoming, we are confident we can address any issue arising from the report. We are also appreciative of the fact that Congressional representatives, realizing the many questions left open by the report, extended the period of time to submit additional information for another 10 days. We look forward to submitting additional input to provide a more complete, more accurate picture of our company and our industry.
In the meantime, we will continue to pursue the path we started on more than two years ago. 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. We look forward to working further with the FDA to develop regulations for our industry at our next meeting with the agency next month. We also look forward to upcoming scientific studies of personal genomics services conducted by researchers at institutions such the Scripps Translational Science Institute, the Mayo Clinic, and Johns Hopkins. These studies, conducted with scientific rigor and involving participants whose only agenda was better understanding of themselves through their personal genetics, will provide useful, informative insights into how consumers interact with genetic information.
As plans for regulation unfold, we stand by our science, our service, and the standards we first proposed in 2008. A full demo version of the genetic results we provide, with no registration or signup required for viewing, is always available to anyone at www.navigenics.com/demo, and a full version of our Informed Consent has also aways been available for viewing without any required registration or signup. The FDA, along with other federal officials, is making productive steps towards a new framework for our industry. We look forward to continuing to be part of the discussion.