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) cervical squamous cell carcinoma tissue using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying patients with recurrent or metastatic cervical cancer for treatment with KEYTRUDA® (pembrolizumab).
PD-L1 22C3 test for other indications may be viewed.
Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.
- 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.
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