DIA Meeting on Companion Diagnostics

Over the last decade, there has been rapid expansion in the knowledge of molecular mechanisms that drive disease and the associated diagnostics and therapies that detect and target these disease drivers. Increasingly, diseases are being recognized as more heterogeneous entities, potentially dividing patients into ever-smaller subsets for individualized therapy. As our knowledge of disease mechanisms continues to evolve, personalized medicine will likely become even more complex, straining the traditional drug-diagnostic development paradigm associated with large, single-sponsor clinical studies. This session reflects on recent efforts to reshape clinical trials for precision therapies and their companion diagnostics, and envisions future activities that may propel the advancement of innovative breakthrough therapies to biomarker-defined patients with high unmet medical need.