VENTANA PD-L1 (SP263) Assay

Predictive IHC assay

PD-L1 SP263 Assay UC stain image
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Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying urothelial carcinoma (UC) patients most likely to benefit from IMFINZI™ (durvalumab). FDA approved. 

Urothelial carcinoma

The VENTANA PD-L1 (SP263) Assay* is the clinical trial enrollment assay for IMFINZITM (durvalumab) and the only PD-L1 assay validated to assess UC patient treatment benefit from this PD-L1 inhibitor. Using a validated assay to determine PD-L1 status for immunotherapies is important. VENTANA PD-L1 (SP263) Assay equips pathologists by:

  • Identifying urothelial carcinoma patients most likely to benefit from IMFINZI (durvalumab)
  • Producing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC)

* In the US only available on the BenchMark ULTRA instrument


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.