Companion diagnostics (CDx) are transforming cancer care by guiding more precise, effective treatments for individual patients. As the foundation of precision medicine in oncology, CDx help identify who will benefit most from specific therapies—yet their development is shaped by complex regulatory and technical challenges.
This guide explores the evolving regulatory landscape, including recent changes affecting laboratory-developed tests (LDTs), and offers practical strategies for integrating CDx into oncology trials. It covers approaches for overcoming biomarker variability, expanding global trial sites, standardizing assays, and adopting adaptive trial designs to accelerate progress in targeted therapies.
Gain a deeper understanding of how to navigate the complexities of CDx and drive innovation in oncology.
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