Ventana VENTANA PD-L1 (SP142) Assay

VENTANA PD-L1 (SP142) Assay is intended for laboratory use in the qualitative 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 indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a BenchMark IHC/ISH instrument. Determination of PD-L1 status is indication-specific and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity. VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies listed below for the respective indications and cutoffs in accordance with the approved therapeutic product labeling. Triple-Negative Breast Carcinoma - TECENTRIQ -≥ 1% IC cutoff