DevicePMAs@therightstef:P160002_S006 JSONTXT 11 Projects

Approval for modifying the intended use of the VENTANA PD-L1(SP142). The VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma and non-small cell lung cancer (NSCLC) tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA 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. PD-L1 expression in >= 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is indicated as an aid in identifying urothelial carcinoma patients for treatment with TECENTRIQ (atezolizumab).PD-L1 expression in >= 50% TC or >= 10% IC determined by VENTANA PD-L1 (SP142) Assay in NSCLC tissue may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).See the TECENTRIQ product label for PD-L1 expression cutoff values guiding therapy in specific clinical circumstances. This product is intended for in vitro diagnostic (IVD) use.