PD-L1 22C3 FDA (KEYTRUDA) for Gastric/GEA

Message
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).


Test Code
LAB5993


Alias/See Also
3546XHSG


CPT Codes
88360

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 22C3 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
Immunohistochemistry (IHC)
 

Report Available
48 hrs




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.