PD-L1 28-8 (OPDIVO®) for Gastric/GEJ/EAC

PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using monoclonal rabbit anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) gastric carcinoma, gastroesophageal junction carcinoma (GEJ) and esophageal adenocarcinoma (EAC) tissues using EnVision FLEX visualization system on Autostainer Link 48. Although PD-L1 testing has not received the FDA-approval for these tumor types, the CHECKMATE 649 Study showed that OPDIVO® (nivolumab) in combination with chemotherapy demonstrated superior overall survival (OS) and progression-free survival (PFS) when compared to chemotherapy alone. Tissues with PD-L1 Combined Positive Score (CPS) 5 are considered to have PD-L1 expression. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturers online interpretation training. All PD-L1 IHC test options may be viewed here.