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VENTANA® PD-L1 (SP263) Assay
US-FDA
IVD
For in vitro diagnostic use.
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Guiding immunotherapy decisions
VENTANA PD-L1 (SP263) Assay identifies patients who are most likely to respond to specific therapy, so that you can make informed, efficient treatment decisions that can lead to better clinical outcomes. 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 carcinoma (NSCLC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
- NSCLC patients eligible for treatment with LIBTAYO® (cemiplimab)
VENTANA PD-L1 (SP263) Assay further benefits patients by:
- 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 PD-L1 (SP263) Assay is a qualitative immunohistochemistry assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the programmed death ligand-1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue specimens by light microscopy. The VENTANA PD-L1 (SP263) Assay is used with the OptiView DAB IHC Detection Kit for staining on the BenchMark ULTRA instrument.
NSCLC:
PD-L1 expression in tumor 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).
PD-L1 expression in tumor 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).
Table 1. Therapy and associated indication.
View Full TableTable 1. Therapy and associated indication.
| Indication for use | Therapy | PD-L1 Expression |
|---|---|---|
| NSCLC | TECENTRIQ® | ≥1 % TC |
| LIBTAYO® | ≥50 % TC |
*IC staining with this assay is not used to assess PD-L1 status in NSCLC.
Overview
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