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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
CPT Code(s): 88360 (reference only; CPTs may vary)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
• 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