On November 12th and 13th, the Food and Drug Administration 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’s Precision Medicine Initiative, 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.

FDA also is actively working to advance the science needed to develop necessary standards for NGS, as evident from the launch of its new crowd-sourced, cloud-based platform called precisionFDA — billed as “a community platform for NGS assay evaluation and regulatory science exploration.” The site launched the night before the NGS workshops began, according to FDA’s Chief Health Informatics Officer Dr. Taha Kass-Hout, who announced the availability of the resource. Dr. Kass-Hout encouraged all scientists and companies working on NGS technologies to check out precisionFDA and provide feedback or contribute reference materials before the beta launch on December 15, calling it the genomic community’s version of a “sandbox to play in.” Following the beta launch, he noted, FDA will be scaling the environment and identifying challenges that need to be addressed next year.