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    PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered PD-L1 positive if TPS ≥ 50% of the viable tumor cells exhibit membrane staining at any intensity.
    Cancer:
    Cervical Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer, Urothelial Cancer
    Gene:
    PD-L1 (Programmed death ligand 1)
    Drug:
    Keytruda (pembrolizumab), Libtayo (cemiplimab-rwlc)
    Method:
    Immunohistochemistry (IHC)
    Confirmatory trial(s)
    KEYNOTE-001
    ,
    NCT01295827
    |
    Clin Cancer Res