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PD-L1 IHC 22C3 pharmDx for Autostainer Link 48

Non-small cell lung cancer

PD-L1 IHC 22C3 pharmDx for Autostainer Link 48

IVD

Code SK006

Intended Use

To measure the proportion of PD-L1 expression in cancer tissue or cells (Indication as an aid for proper administration of pembrolizumab [recombinant] in non-small cell lung cancer patients, head and neck cancer patients, esophageal cancer patients and breast cancer patients.)

PD-L1 IHC 22C3 pharmDx 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), head and neck cancer (HNC), esophageal squamous cell carcinoma (ESCC) and triple-negative breast cancer (TNBC) tissues using 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 HNC, ESCC and TNBC 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.

See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.

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

PD-L1 IHC 22C3 pharmDx

The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing positive and negative PD-L1 protein expression, 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).

Read more about PD-L1 IHC 22C3 pharmDx.

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

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