Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Request for Comments

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests''. The purpose of this workshop is to obtain feedback on possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA's regulatory approach to next generation sequencing (NGS)-based in vitro diagnostic tests. Comments and suggestions generated through this workshop will also guide the use of regulatory science to advance the development of appropriate and relevant performance standards for evaluation of NGS in vitro diagnostic tests that produce results on variation in the human genome.