PD-L1 IHC 22C3 pharmDx, Code GE006
IVD
For in vitro diagnostic use
PD-L1 IHC 22C3 pharmDx, Code GE006, 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, Code GE006, is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for approved indications and expression cutoff values guiding therapy and specific clinical circumstances guiding PD-L1 testing.
PD-L1 IHC 22C3 pharmDx, Code GE006, 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, Code GE006, is intended for use. Instrument compatibility may also vary by region. Please refer to the region-specific Instructions For Use to confirm compatibility with your instrument setup.
PD-L1 IHC 22C3 pharmDx, Code GE006, includes 12 mL of PD-L1 Primary Antibody and 12 mL of Negative Control Reagent in ready-to-use format. The assay is a modular IHC assay for 60 tests: 60 slides incubated with the primary antibody to PD-L1 protein and 60 slides incubated with the Negative Control Reagent.
Refer to the region-specific Instructions For Use for the complete list of materials that are required but not supplied with PD-L1 IHC 22C3 pharmDx, Code GE006.
For details on staining interpretation, refer to the region-specific Instructions For Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manuals.
PD-L1 IHC 22C3 pharmDx, Code GE006, 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
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.
