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PD-L1 22C3 FDA (KEYTRUDA) for HNSCC (Head & Neck)
MessagePD-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) head and neck squamous cell carcinoma (HNSCC) and certain other tissues using EnVision FLEX visualization system on Autostainer Link 48.
Test Code
LAB6175
Alias/See Also
PD-L1, 22C3, KEYTRUDA
CPT Codes
88360x1
Preferred Specimen
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered. Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition. For PD-L1 22C3 evaluation, tissue submitted must have ≥100 viable tumor cells present.
Instructions
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Methodology
IHC
Report Available
48 hours
Clinical Significance
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab). KEYTRUDA® is approved for use in some HNSCC patients whose tumors express PD-L1 with Combined Positive Score (CPS) ≥ 1.
Performing Laboratory
Neogenomics Laboratories
