VENTANA PD-L1 (SP263) Assay

PD-L1 predictive assays | Guiding immunotherapy 

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

  • Non-small cell lung cancer (NSCLC) patients eligible for treatment with KEYTRUDA® (pembrolizumab) [CE mark only, not FDA approved]
  • Non-squamous NSCLC patients most likely to benefit from OPDIVO® (nivolumab) [CE mark only, not FDA approved]
  • Urothelial carcinoma (UC) patients most likely to benefit from IMFINZI™ (durvalumab) [FDA approved in the US]
> Learn more about the CE IVD label expansion to include KEYTRUDA®
> Click here for the US testing information

Non-small cell lung cancer [CE mark only, not FDA approved]

Empowering pathologist to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay expands immunotherapy options for NSCLC patients through equipping pathologists by:

  • Identifying NSCLC patients eligible for treatment with KEYTRUDA (pembrolizumab)** 
  • Identifying non-squamous NSCLC patients most likely to benefit from OPDIVO (nivolumab)**
  • Providing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC)†
  • Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months

**Ventana relied on a method comparison study carried out by AstraZeneca, which compares data from currently available PD-L1 assays, PD-L1 IHC 22C3 pharmDx (used in the clinical studies of KEYTRUDA), PD-L1 IHC 28-8 pharmDx (used in the clinical studies of OPDIVO), and VENTANA PD-L1 (SP263) Assay.

†IC staining with this assay is not used to assess PD-L1 status for KEYTRUDA or OPDIVO in NSCLC. 


 

Urothelial carcinoma

Empowering pathologist to answer PD-L1 questions

The VENTANA PD-L1 (SP263) Assay* is the first and only FDA approved test predictive for IMFINZI (durvalumab) in urothelial carcinoma (UC) patients. PD-L1 expression in ≥ 25% tumor cells or tumor-associated immune cells in urothelial carcinoma tissue, as determined by VENTANA PD-L1 (SP263) Assay, is associated with increased objective response rate (ORR) in a non-randomized study of IMFINZI (durvalumab).

  • FDA approved to predict UC patient response to IMFINZI
  • Provides 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.


 

PD-L1 analytic assay

VENTANA analytic assays evaluate for expression of PD-L1 in tumor and immune cells in the context of the tumor microenvironment.

VENTANA PD-L1 (SP263)
Rabbit Monoclonal Primary Antibody
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The PD-L1 immunologic checkpoint

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The tumor microenvironment