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 certain types of formalin-fixed, paraffin-embedded (FFPE) cancer tissues using EnVision FLEX visualization system on Autostainer Link 48.
Depending on the cancer type under investigation, PD-L1 protein expression is determined by using either Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity, or 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 IHC 22C3 pharmDx is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA® (pembrolizumab). Please refer to the full intended use of PD-L1 IHC 22C3 pharmDx for indications and PD-L1 expression levels.
For details on staining interpretation, refer to the 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 wash buffer), control slides representing positive and negative PD-L1 protein expression, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. 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).
Read more about PD-L1 IHC 22C3 pharmDx.
For countries outside of the United States and the EU, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.