The Centers for Disease Control and the National Institutes of Health are working together to create a Genomics Knowledge Synthesis Center and are seeking cooperative research agreements with the private sector to help fund and advance the work of this Center. (CDC Announcement) The overall objective of the Center is to review genomic research and move it into “clinical and public health practice in ways that maximize health benefits and minimize harms to individuals and populations.”
Whatever entity is selected to operate the Center will conduct and publish systematic evidence reviews to examine analytic validity, clinical validity and clinical utility, as well as any social and ethical issues from use of genomic tests and information. These will be made publicly available. The announcement notes that while there has been a rapid growth in tests, including those offered directly to consumers, there has been less work on the validity and usefulness of them and concern has been expressed about the adequacy of current regulatory oversight.
Personalized medicine is an exciting field, and offers the potential for tremendous improvement in medical care and health outcomes. It could dramatically reshape how care is delivered. But, like many exciting developments, it will move forward most successfully if it does so in an evidence-based framework that doesn’t lead to excessive expectations and many early disappointments, or much worse, episodes of inadequate care; all of which might raise barriers to personalized medicine’s ultimate growth. Industry should welcome thoughtful regulatory approaches to help ensure the credibility of the field.