CAP Urges FDA To Use Industry Standards, 3rd-Party Inspectors To Oversee NGS

As FDA strives to develop a regulatory structure to match the rapid advancements in the technology for diagnostic testing, a group representing pathologists stresses much of the groundwork for development of guidelines and standards has already been laid by professional societies. The agency recently solicited feedback from stakeholders on how it could best regulate next-generation sequencing tests. The College of American Pathologists was one of the initial organizations to pioneer a set of standards with which to validate labs performing...