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) gastric or gastroesophageal junction adenocarcinoma (GEJ, GEA) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying patients with metastatic gastric or GEJ cancer for treatment with KEYTRUDA® (pembrolizumab).
For cervical cancer, please order PD-L1 22C3 FDA (KEYTRUDA®) for Cervical. For urothelial (bladder) carcinoma, please order PD-L1 22C3 FDA (KEYTRUDA®) for Urothelial Carcinoma. For non-small cell lung carcinoma (NSCLC), please order PD-L1 22C3 FDA (KEYTRUDA®) for NSCLC.
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
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.
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