To view associated reagents, ancillaries and bulks, please visit the Roche Tissue Diagnostics reagent catalog.
Predictive IHC assay
VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying urothelial carcinoma (UC) patients most likely to benefit from IMFINZI™ (durvalumab). FDA approved.
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:
* 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:
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.