Integrating Companion Diagnostic Assays into Drug Development: Addressing the Challenges from the Diagnostic Perspective

Preclinical Research The drug development process is witnessing a paradigm shift in which new therapies need to be tailored to well-defined patient subgroups via companion diagnostic assays. This codevelopment paradigm is fostering a new set of partnerships between pharmaceutical and diagnostic developers. Although initial results have illustrated transformative effects associated with the codevelopment process, continued success in the development and commercialization of these paired products will require addressing the challenges and identifying strategies to guarantee future success.