Given the recent approval by the US Food and Drug Administration of an anti-programmed cell death protein 1 agent as a first-line therapy for patients with advanced non-small cell lung cancer, programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) testing has become routine in pathology laboratories in the United States. Each pathology laboratory needs to select a PD-L1 IHC assay among the multiple assays available, conduct appropriate optimization and validation processes, and pay close attention to appropriate preanalytical tissue handling and the selection of optimal tissue samples. See also pages 000-000.
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