For localized information and support, would you like to switch to your country-specific website for {0}?
VENTANA® PD-L1 (SP263) Assay
CE-IVD
IVD
For in vitro diagnostic use.
Use left and right arrow keys to scroll between the tabs
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.
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 IMFINZI, KEYTRUDA, OPDIVO, LIBTAYO or TECENTRIQ 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.
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 TableTable 1. Therapy and associated indication.
| Indication for use | Therapy | PD-L1 expression |
|---|---|---|
| NSCLC | IMFINZI® | ≥ 1% TC |
| KEYTRUDA® | ≥ 50% TC | |
| ≥ 1% TC | ||
| LIBTAYO® | ≥ 50% TC | |
| ≥ 1% TC | ||
| TECENTRIQ® | ≥ 50% TC | |
| Non-squamous NSCLC | OPDIVO® | ≥ 1%, ≥ 5% and ≥ 10% |
Overview
Technical Documents
Access important product documentation including relevant certificates and other resources.
After clicking below, you will be redirected to eLabDoc, where you can select your local country-specific documents.
