VENTANA PD-L1 (SP142) Assay - Immunohistology cell marker IVDs

Intended purpose

VENTANA PD-L1 (SP142) Assay is intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tissues stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a BenchMark IHC/ISH instrument. It is indicated as an aid for identifying urothelial carcinoma patients with ≥ 5% PD-L1 expressing tumor-infiltrating immune cells (IC) for treatment with Tecentriq® (atezolizumab) in accordance with the approved therapeutic product labeling. VENTANA PD-L1 (SP142) Assay may be associated with enhanced patient benefit with Tecentriq® (atezolizumab) for Non-Small Cell Lung Cancer (NSCLC) with ≥ 50% PD-L1 expressing tumor cells (TC) or ≥ 10% IC in accordance with the approved therapeutic product labeling.

Functional description

Immunohistochemical staining of tissues for PD-L1 protein as an aid in identifying patients eligible for treatment with nominated therapies in selected indications