PD-L1 Imfinzi by IHC

Alphabetical Test listing

PD-L1 Imfinzi by IHC-Pathology add-on

PD-L1 Imfinzi by IHC
Pathology add-on

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.


Prepare a formalin-fixed, paraffin-embedded (FFPE) tissue block


FFPE tissue block


Histopathology add-on requestion


Ambient (strict) - Indefinitely

Refrigerated – NO

Frozen – NO


Insufficient tissue in block

NeoGenomics: R-NX
Mo - Fr
48 - 72 hours

Immunohistochemical staining and interpretation