Non-small cell lung cancer
PD-L1 IHC 22C3 pharmDx for Dako Omnis
IVD
For in vitro diagnostics 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 formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) tissues, using EnVision FLEX visualization system on Dako Omnis.
PD-L1 protein expression in NSCLC 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 protein expression in HNSCC is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
PD-L1 IHC 22C3 pharmDx, Code GE006, is indicated as an aid in identifying NSCLC and HNSCC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.
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 Instructions for Use (IFU) for the complete list of materials that are required but not supplied with PD-L1 IHC 22C3 pharmDx, Code GE006.
For countries outside of the United States, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.
PD-L1 IHC 22C3 pharmDx 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.
For In Vitro Diagnostic Use.
Product Details
Features
- Validated assay to identify non-small cell lung cancer patients eligible for KEYTRUDA (pembrolizuma)
- 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.
4. Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M, De Castro G, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. The Lancet 2019, 394 (10212), 1915–1928. https://doi.org/10.1016/s0140-6736(19)32591-7.
