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
Have any questions?
CONTACT US
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 IMFINZITM (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)

 

Non-small cell lung cancer (NSCLC)

VENTANA PD-L1 (SP263) Assay expands immunotherapy options by equipping pathologists to:

 
  • Identify NSCLC patients eligible for treatment with IMFINZI (durvalumab)
  • Identify NSCLC patients eligible for treatment with KEYTRUDA (pembrolizumab)**
  • Identify non-squamous NSCLC patients most likely to benefit from OPDIVO (nivolumab)**
  • Identify NSCLC patients eligible for treatment with LIBTAYO (cemiplimab)

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 

 

**Based 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 for 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.    

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 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).


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.

View Full Table

Table 1. Therapy and associated indication.

Indication for use Therapy PD-L1 Expression-Therapeutic Line
NSCLC IMFINZI™ ≥ 1% TC –Post chemoradiation therapy (CRT)
KEYTRUDA® ≥50% TC – First Line
≥1% TC – Second Line
OPDIVO® ≥1%, ≥5% and ≥10% TC – Second Line
LIBTAYO® 50% TC - First Line