7 November 2008
The report explains some of the barriers preventing widespread adoption of personalised medicine such as ambiguous regulation, lack of translational research and limited coverage by health insurers, as well as potential mechanisms to overcome them. Its recommendations include calling on the US federal government to develop a strategic long-term plan that coordinates public and private sector efforts to advance research and development relevant to personalised medicine, and in particular the US Department of Health and Human Services (HHS) to establish a personalised medicine coordinating office. It also calls for a more transparent, iterative and systematic approach to regulation by the US Food and Drug Administration (FDA).
One of the obstacles in the regulation of molecular diagnostics are the difficulties in demonstrating clinical utility and validity; to address this, PCAST suggests government funding for development of tools which would allow standardisation and evaluation of molecular diagnostics, as well as increased cooperation with and endeavour by industry to demonstrate the utility of their developments. In addition, they also recommend a balance between funding for discovery and translational research in order to ensure that new discoveries are better able to reach clinical practice.
Much of the report echoes and re-iterates the PHG Foundation’s findings in relation to the evaluation of genetic tests and molecular biomarkers, which is an area of ongoing focus at national and international levels. With more diagnostic tests becoming available all the time, it is becoming increasingly important to produce appropriate mechanisms to assess and evaluate them, to distinguish between clinically useful and redundant tools, and to understand their possible impact on clinical practice. However, this requires not only investment in the discovery and development of new biomedical technologies, but also translational efforts including resources to reliably determine their benefits.