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) head and neck squamous cell carcinoma (HNSCC) and certain other tissues using EnVision FLEX visualization system on Autostainer Link 48. 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.
For other tumor types with approved indications for this test, please search our Test Menu for "22C3" to see available options.
- A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or
- One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 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.
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Global: 48 hours