PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical (IHC) 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), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), esophageal cancer, and cervical cancer tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity.
PD-L1 protein expression in TNBC, esophageal cancer, and cervical cancer is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
PD-L1 protein expression in HNSCC is determined by using CPS and/or TPS.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC, HNSCC, TNBC, esophageal cancer and cervical cancer patients for treatment with KEYTRUDA® (pembrolizumab).
See the local KEYTRUDA® product label for approved indications and expression cutoff values to guide therapy.
For details on staining interpretation, refer to the local PD-L1 IHC 22C3 pharmDx Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manuals.PD-L1 IHC 22C3 pharmDx kit
The kit includes reagents required for the immunohistochemical staining (except EnVision FLEX Wash Buffer and Hematoxylin (Link), control cell line slides representing different expression levels of PD-L1 protein, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instrument. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal mouse antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
For In Vitro Diagnostic Use.