The VENTANA PD-L1 (SP263) assay is an FDA-approved complementary diagnostic IHC test for PD-L1 status in patients with locally advanced or metastatic urothelial carcinoma (mUC) who are being considered for treatment with  IMFINZI™ (durvalumab).

This 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 high expression status as determined by this assay was associated with increased objective response rate (ORR) in a single arm study of durvalumab.