On February 20, 2015, the FDA is hosting a public workshop on “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of the workshop is to receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology. As pointed out in an FDA preliminary discussion paper, “NGS tests are unique among existing [in vitro diagnostics] in the amount of data that can be generated, the lack of an a priori definition of what will be detected, and the number of clinical interpretations that can be made from a single patient sample.” The FDA is considering several regulatory approaches to regulating NGS tests, including a standards-based approach to analytical performance of NGS tests and the use of centralized curated databases containing up-to-date evidence to support clinical performance.
