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) esophageal squamous cell carcinoma (ESCC) 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 ESCC patients for treatment with KEYTRUDA® (pembrolizumab). KEYTRUDA® is approved for use in some ESCC patients whose tumors express PD-L1 with Combined Positive Score (CPS) ≥ 10.
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
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.
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Global: 48 hours, Tech-Only (stain only): 24 hours
2. KEYTRUDA® (pembrolizumab) [package insert]. Whitehouse Station, NJ: Merck & C o., Inc: uspi-mk3475-iv-1907r029