PD-L1 (SP263) Assay, VENTANA

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DIAGNOSTICS F. Hoffmann-La Roche Ltd

VENTANA PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay, urothelial carcinoma
Catalog Number:740-4907
Ordering Code:07208162001
Quantity:50 tests
Clone Name:SP263
Localization:Membranous and/or Cytoplasmic Staining
Regulatory Status:IVD

VENTANA PD-L1 (SP263) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue stained with OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument.

PD-L1 status is determined by the percentage of tumor cells with any membrane staining above background or by the percentage of tumor-associated immune cells with staining (IC+) at any intensity above background. The percent of tumor area occupied by any tumor-associated immune cells (Immune Cells Present, ICP) is used to determine IC+, which is the percent area of ICP exhibiting PD-L1 positive immune cell staining. PD-L1 status is considered High if any of the following are met:

  • ≥ 25% of tumor cells exhibit membrane staining; or,
  • ICP > 1% and IC+ ≥ 25%; or,
  • ICP = 1% and IC+ = 100%

PD-L1 High status as determined by VENTANA PD-L1 (SP263) Assay was associated with increased objective response rate (ORR) in a single arm study of IMFINZI™ (durvalumab).

This antibody is intended for in vitro diagnostic (IVD) use.

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