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 formalin-fixed, paraffin-embedded (FFPE) cancer tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA® (pembrolizumab). PD-L1 IHC 22C3 pharmDx is intended for use in specific types of cancer, which may vary by region. Please refer to the local Instructions for Use for a description of the types of cancer in which PD-L1 IHC 22C3 pharmDx is intended for use.
PD-L1 IHC 22C3 pharmDx
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).
For details on staining interpretation, refer to the Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manuals.
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.