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.

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)