VENTANA PD-L1 (SP263) Assay

Guiding immunotherapy


PD-L1 Predictive Assays: Guiding Immunotherapy

PD-L1 is an informative immunotherapy biomarker: Aberrant expression of PD-L1 on tumor and immune cells in the tumor microenvironment impedes anti-tumor immunity, allowing tumors to grow and metastasize.

Lung Cancer


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VENTANA PD-L1 predictive assays assess the degree and likelihood of potential patient benefit from corresponding PD-1/PD-L1 immunotherapies. The link between assay results and patient benefit has been established and verified in studies. 

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying urothelial carcinoma (UC) patients most likely to benefit from IMFINZI™ (durvalumab) [FDA approved in the US and CE mark]

Urothelial carcinoma [CE mark and FDA approved]

Empowering pathologists to answer PD-L1 questions

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)
  • Providing access to multiple immunotherapy options for different cancer types** 


* In the US only available on the BenchMark ULTRA Instrument

** VENTANA PD-L1 (SP263) Assay is also CE marked for OPDIVO and KEYTRUDA in NSCLC


The PD-L1 immunologic checkpoint

About PD-L1

The tumor microenvironment