This insight brief examines the critical role of companion diagnostics (CDx) in enabling personalized medicine and improving patient outcomes. Using the FDA approval of the PD-L1 IHC 22C3 pharmDx assay as an example, it illustrates how diagnostics guide treatment selection for targeted therapies such as immuno-oncology drugs. The brief outlines the regulatory complexity of CDx development, which requires close coordination between drug and diagnostic timelines, evidence generation, and regulatory submissions. It highlights key challenges for MedTech innovators, including aligning with evolving FDA expectations, managing co-development risks, and ensuring analytical and clinical validity. IQVIA emphasizes the importance of early regulatory strategy, cross-functional collaboration, and integ

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