Non-small cell lung cancer
PD-L1 IHC 22C3 pharmDx (Dako Omnis)
CE-IVD
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 LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
For In Vitro Diagnostic Use.
Product Details
Features
- Validated assay to identify non-small cell lung cancer patients eligible for KEYTRUDA (pembrolizumab)
- Fully automated and workflow-optimized PD-L1 assay that enables lung cancer case management on Dako Omnis
Featured References
- Product Description References
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1. Dolled-Filhart M, Roach C, Toland G, Stanforth D, Jansson M, Lubiniecki GM, et al. Development of a companion diagnostic for pembrolizumab in non-small cell lung cancer using immunohistochemistry for programmed death ligand-1. Arch Pathol Lab Med 2016;140(11):1243-9.
2. Herbst RS, Baas P, Kim DW, Felip E, Perez-Gracia JL, Han, JY, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016;387(10027):1540-50.
3. Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823-33.
