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 and CE mark]
> 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 [CE mark and FDA approved]

 

Empowering pathologist 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


 

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