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VENTANA PD-L1 (SP263) Assay (US FDA Approved)

Predictive IHC assay

PD-L1 SP263 Assay UC stain image

Guiding immunotherapy decisions

VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.

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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

 

Related information

 

US testing information

Online training for pathologists

The PD-L1 immunologic checkpoint 

The tumor microenvironment 

About PD-L1: Rewriting the book on immunotherapy

Learn more about Personalized Healthcare (PHC)

IMFINZI.com

Reagent catalog

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.