Test Method
IHC
CPT Code
88360
Stains / Test Description
The PD-L1 (SP263) Assay is used in the assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor infiltrating immune cells and is used as a companion diagnostic test for use of Imfinzi in the treatment of gastric/gastroesophageal carcinoma, melanoma, and urothelial carcinoma.
Specimen Requirements
(1) H&E slide with formalin-fixed, paraffin-embedded (FFPE) tissue, fixed with 10% NBF.
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 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.
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 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.
Storage & Transport
Ship specimen same day (whenever possible) with refrigerated (not frozen) cold pack
Turnaround time
1-3 days depending on level of service
Level of Service
Global (with interpretation)
Slide Only (glass slides only)
Slide Only (glass slides only)