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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, Epithelial Ovarian Cancer, Esophageal Squamous Cell Carcinoma, Fallopian Tube Cancer, 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)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    10/02/15
    NSCLC
    PD-L1
    pembrolizumab
    FDA (PMA)
    06/12/18
    CC
    PD-L1
    pembrolizumab
    FDA (PMA)
    06/10/19
    SCCHN
    PD-L1
    pembrolizumab
    FDA (PMA)
    07/30/19
    ESCC
    PD-L1
    pembrolizumab
    FDA (PMA)
    11/21/19
    SCCHN
    PD-L1
    pembrolizumab
    CE-IVDR (New IVDR)
    11/13/20
    TNBC
    PD-L1
    pembrolizumab
    FDA (PMA)
    See More ...
    Confirmatory trial(s)
    KEYNOTE-001
    ,
    NCT01295827
    |
    Clin Cancer Res