CE-IVD
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.
* 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.
| 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% |
