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.
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