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VENTANA PD-L1 (SP263) Assay (CE IVD)

Predictive IHC assay

VENTANA PD-L1 (SP263) Assay, non-small cell lung cancer (NSCLC), urothelial carcinoma, bladder cancer

Guiding immunotherapy decisions

VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.

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Empowering pathologists to answer PD-L1 questions
VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

 

  • Non-small cell lung cancer (NSCLC) patients eligible for treatment with IMFINZI® (durvalumab)
  • NSCLC patients eligible for treatment with KEYTRUDA® (pembrolizumab)
  • Non-squamous NSCLC patients most likely to benefit from OPDIVO® (nivolumab)
  • NSCLC patients eligible for treatment with LIBTAYO® (cemiplimab)
  • NSCLC patients eligible for treatment with TECENTRIQ® (atezolizumab)

 

VENTANA PD-L1 (SP263) Assay further benefits patients by:

 

  • Providing robust PD-L1 staining in both tumour cells (TC) and tumour-infiltrating immune cells (IC)†
  • Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months 
†IC staining with this assay is not used to assess PD-L1 status for KEYTRUDA, OPDIVO, LIBTAYO or TECENTRIQ in NSCLC.    

Related information

VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), tissue stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.

NSCLC:

PD-L1 expression in tumour cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with IMFINZI® (durvalumab).

PD-L1 expression in tumour cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with KEYTRUDA® (pembrolizumab).

PD-L1 expression in tumour cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). 

PD-L1 expression in tumour cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with LIBTAYO® (cemiplimab).

PD-L1 expression in tumour cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with TECENTRIQ® (atezolizumab)


This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.

The assay is intended for identifying patients who may benefit from therapy as shown in Table 1. Please refer to the respective drug labeling for clinical recommendations pertaining to PD-L1 expression.

 

Table 1. Therapy and associated indication.

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Table 1. Therapy and associated indication.

 

Indication for use Therapy PD-L1 expression
NSCLC IMFINZI® ≥ 1% TC 
KEYTRUDA® ≥50% TC 
≥1% TC 
LIBTAYO® ≥50% TC 
TECENTRIQ® ≥50% TC 
Non-squamous NSCLC OPDIVO® ≥1%, ≥5% and ≥10%