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) triple-negative breast cancer (TNBC) tissue using EnVision FLEX visualization system on Autostainer Link 48. This test is indicated as an aid in identifying TNBC patients for treatment with KEYTRUDA® (pembrolizumab). Tissues with PD-L1 Combined Positive Score (CPS) ≥ 10 are considered positive.
Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.
All PD-L1 IHC test options may be viewed here.
PD-L1 22C3 FDA (KEYTRUDA®) for TNBC is a companion diagnostic (CDx) for certain triple-negative breast cancer patients. PD-L1 expression with ≥10% Combined Positive Score (CPS) may be associated with increased progression-free survival in patients with metastatic or advanced, locally unresectable TNBC treated with KEYTRUDA® and chemotherapy.
- 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
- PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako; PT0020/Rev F.
- KEYTRUDA® (pembrolizumab) [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; usmg-mk3475-iv-2011r036