FDA Hosts Genome Scientists For Next-Generation Sequencing Conference -

Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various technical aspects of translating Next-Generation Sequencing (NGS) into clinical practice, including issues related to analytical performance evaluation, bioinformatics strategies, and the use of genetic databases to establish clinical validity of a test. Although at this stage, FDA has not developed a new regulatory framework for NGS that is distinct from the process for more traditional diagnostic tests, the Agency’s stated goal is to institute “appropriate oversight, in a way that is more suitable to the complexity and data-richness of this new technology.” These activities are being driven by the President Obama’s Precision Medicine Initiative, bipartisan and bicameral interest on Capitol Hill, as well as health care market realities that patients and their physicians want to choose the right treatment, at the right time, with hopefully minimal side effects.

Numerous federal agencies have taken steps to implement the Precision Medicine Initiative - which the President announced at the 2015 State of the Union. For example, the National Institutes of Health approved a blueprint for the initiative which seeks to enroll one million volunteers in the next five years to evaluate an individual’s risk of developing a disease. The study would look at both genetic and environmental factors. The FDA workshop last week was also in step with the President’s initiative.