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 for use on Dako Omnis.
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 on Dako Omnis
The assay is a modular IHC assay for 60 tests. The assay has been tailored especially with EnVision FLEX visualization system on the Dako Omnis instrument. The complete assay consists of the following components (to be ordered separately):
PD-L1 IHC 22C3 pharmDx (Dako Omnis) (GE00621-2) - EnVision FLEX, High pH (Dako Omnis) (GV80011-2) - EnVision FLEX Target Retrieval Solution, Low pH (50x) (GV80511-2) - EnVision FLEX+ Mouse Linker (Dako Omnis) (GV82111-2) - EnVision FLEX DAB Enhancer (Dako Omnis) (GC80611-2) - PD-L1 Control Slides (T139130-2)
The assay requires Low pH Target Retrieval, Mouse Linker and a DAB Enhancer but the PD-L1 Control Slides are optional.
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.
For In Vitro Diagnostic Use.