DIA Meeting on Companion Diagnostics

Multiple marker diagnostics (multiplex) or next-generation sequencing (NGS) platforms offer the ability to test for a wide array of biomarkers and mutations at once. These platforms can be instrumental in fostering efficient health care utilization, maximizing sampling for tissue/specimen/biopsy and advancing innovations in molecularly-targeted therapeutic development and registration across a variety of therapy areas. There are several regulatory and development strategic considerations when employing a multiple marker diagnostic approach in a therapeutic development program. This session will explore challenges and opportunities of utilizing a multiple marker approach including test, bridging, analytical validation and labeling.