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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) non-squamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab)."
Cancer:
Esophageal Squamous Cell Carcinoma, Lung Non-Squamous Non-Small Cell Cancer, Melanoma, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Cancer
Gene:
PD-L1 (Programmed death ligand 1)
Drug:
Opdivo (nivolumab), Yervoy (ipilimumab)
Method:
Immunohistochemistry (IHC)
Approvals
Date
Cancer
Gene
Drug
By
10/21/21
CE