CDx, NGS and regulation: five perspectives from the Pistoia Alliance
Dr Stewart McWilliams, VP of Quality and Regulatory Affairs at Almac Diagnostic Services, in conjunction with John Wise and Mike Furness from the Pistoia Alliance and Simon Patton from EMQN have produced an interesting paper on CDx, NGS and Regulation – Five Perspectives.
Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate. This paper outlines some of the challenges and opportunities perceived by the biopharmaceutical industry, the Europe Molecular Quality Network, a regulatory agency, a notified body, and a CDx service provider.