Non-small cell lung cancer

PD-L1 IHC 22C3 pharmDx for Autostainer Link 48

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Code SK006

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PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC) and head and neck squamous cell carcinoma (HNSCC) tissues. PD-L1 IHC 22C3 pharmDx is a companion diagnostic that is indicated as an aid in identifying NSCLC, ESCC and HNSCC patients for treatment with KEYTRUDA® (pembrolizumab).

PD-L1 IHC 22C3 pharmDx is an immunohistochemical assay using monoclonal mouse anti-PD-L1, Clone 22C3, and EnVision FLEX visualization system on Autostainer Link 48.

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 ESCC 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 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 is indicated as an aid in identifying NSCLC, ESCC, and HNSCC patients for treatment with KEYTRUDA® (pembrolizumab). For indications and PD-L1 expression levels, refer to the full intended use in the Instructions for Use (IFU) for PD-L1 IHC 22C3 pharmDx.

For details on staining interpretation, refer to Staining and Scoring Interpretation section of the Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manual.

PD-L1 IHC 22C3 pharmDx kit

The kit includes reagents required for the immunohistochemical staining (except wash buffer and Hematoxylin (Link)), control slides representing different expression levels of PD-L1 protein, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal mouse antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).

Learn more about PD-L1 IHC 22C3.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Please kindly refer to IFU for limitations and precautions.

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For In Vitro Diagnostic Use.

PD-L1 IHC 22C3 pharmDx

Featured References

Product Description References: 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. Roach C, Zhang N, Corigliano E, Jansson M, Toland G, Ponto G, et al. Development of a companion diagnostic PD-L1 immunohistochemistry assay for pembrolizumab therapy in non-small-cell lung cancer. Appl Immunohistochem Mol Morphol 2016;24:392-7.
3. Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. New Eng J Med 2015;372:2018-28.
4. Herbst RS, Baas P, Kim DW, Felip E, Pérez-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.
5. Reck, M, et al. Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer. N Engl J Med 2016;375:1823-33.
6. Kojima T, Muro K, Francois E, Hsu C-H, Moriwaki T, Kim S-B, et al. Pembrolizumab vs chemotherapy as second-line therapy for advanced esophageal cancer: Phase 3 KEYNOTE-181 study. J Clin Oncol. 2019;37(Supp 4):abstr 2.
7. Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M 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 randomized, open-label, phase 3 study. Lancet 2019;394(10212):1915-28.

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PD-L1 IHC 22C3 pharmDx for Autostainer Link 48

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