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PD-L1 28-8 FDA for NSCLC
MessagePD-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.
Test Code
LAB6415
Alias/See Also
Formerly named PD-L1 28-8 FDA (OPDIVO® + YERVOY®) for NSCLC
CPT Codes
88360x1
Preferred Specimen
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
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
Instructions
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Methodology
IHC
Report Available
48 hours
Clinical Significance
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).
Performing Laboratory
Neogenomics Laboratories
