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Predictive IHC assay
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.
**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 of 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), urothelial carcinoma (UC) tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.
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 IMFINZI™ (durvalumab).
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 KEYTRUDA® (pembrolizumab).
PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).
PD-L1 High status as determined by VENTANA PD-L1 (SP263) Assay was associated with increased objective response rate (ORR) in a single arm study of IMFINZI™ (durvalumab). PD-L1 status is determined by the percentage of tumor cells with any membrane staining above background or by the percentage of tumor-associated immune cells with staining (IC+) at any intensity above background. The percent of tumor area occupied by any tumor-associated immune cells (Immune Cells Present, ICP) is used to determine IC+, which is the percent area of ICP exhibiting PD-L1 positive immune cell staining.
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|
|UC||IMFINZI™||PD-L1 status is considered High if any of the following are met:
• ≥25% TC membrane staining; or,
• ICP > 1% and IC+ ≥ 25%; or,
• ICP = 1% and IC+ = 100%.
– Second Line