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PD-L1 (clone SP142) pin

IHC

PD-L1 (clone SP142)

Methodology: IHC

Clinical Significance:
VENTANA PD-L1 (SP142) assay is an FDA approved IVD assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for assessment of the PD-L1 protein in urothelial carcinoma tissue. PD-L1 status is determined by the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (%IC) of any intensity. PD-L1 expression in ≥ 5% IC determined by VENTANA PD-L1 (SP142) assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of Atezolizumab. Subcellular Localization: Membranous (on immune cells)

Organ: Genitourinary Tumors

Disease State:

CPT Code(s): 88360. The CPT codes provided 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 payer being billed.

Turnaround Time: Within 1-2 business days of receipt

Schedule: Monday - Friday

Specimen Requirements:
• Formalin-fixed, paraffin-embedded (FFPE) tissue block - OR - • 2 unstained slides for each test requested plus 3-4 additional unstained slides cut at 4µm Decalcified specimens are unacceptable Slides should be stained promptly, as antigenicity of cut tissue sections may diminish over time and may be compromised 3 months after cutting from the paraffin block for urothelial carcinoma specimens, 2 months for NSCLC, TNBC, and tonsil specimens.