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PD-L1 IHC 22C3 pharmDx (Dako Omnis)

Non-small cell lung cancer

PD-L1 IHC 22C3 pharmDx (Dako Omnis)

CE-IVD

Code GE006

PD-L1 IHC 22C3 pharmDx (Dako Omnis) 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 Dako Omnis.

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 at any intensity.

PD-L1 IHC 22C3 pharmDx (Dako Omnis) is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab) monotherapy. See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances guiding PD-L1 testing.

PD-L1 IHC 22C3 pharmDx (Dako Omnis) Assay
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.

PD-L1 IHC 22C3 pharmDx (Dako Omnis) is subject to an exclusive trademark license to Dako Denmark A/S. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
For In Vitro Diagnostic Use.

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