Step 1: click on the link below to go to Roche DiaLog.
Step 2: select eLabDoc from eServices.
Step 3: select the Catalog for Healthcare Professionals and search.
Predictive IHC assay
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.
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 | |
TECENTRIQ® | ≥50% TC | |
Non-squamous NSCLC | OPDIVO® | ≥1%, ≥5% and ≥10% |