PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) or OPDIVO in combination with YERVOY® (ipilimumab). Results are considered positive for either treatment when PD-L1 is expressed in ≥1% of tumor cells (TC).
Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.
Please note: PD-L1 testing is not required for use of OPDIVO® in non-squamous NSCLC, head and neck squamous cell carcinoma or urothelial carcinoma, but may provide physicians more information and inform patient dialogue.
- 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 28-8 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
- PD-L1 IHC 28-8 pharmDx [package insert]. Carpinteria, CA: Dako;