For in vitro diagnostic use. Others DLL3 SP347 RxDx Assay IVD Normal Lung Small Cell Lung Carcinoma (positive) VENTANA® DLL3 (SP347) RxDx Assay PID00000550 08124680001 VENTANA DLL3 (SP347) IUO Assay VENTANA DLL3 (SP347) IUO Assay 07613336141847 Reagents, kits 742-6041 50 tests Not Available undefined VENTANA DLL3 (SP347) RxDx Assay is intended for the qualitative detection of Delta-like protein 3 (DLL3) in formalin-fixed, paraffin-embedded (FFPE) small cell lung cancer (SCLC) tissue stained with a VENTANA BenchMark ULTRA instrument. It is indicated as an aid in identifying patients eligible for treatment with rovalpituzumab tesirine.This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. en VENTANA DLL3 (SP347) RxDx Assay uses a rabbit monoclonal antibody produced against the DLL3 protein in paraffin-embedded tissue sections. The specific antibody can be localized using a cocktail of secondary antibodies that is recognized by an enzyme bound tertiary antibody that is visualized with hydrogen peroxide substrate and 3,3'- diaminobenzidine tetrahydrochloride (DAB) chromogen (OptiView DAB IHC Detection Kit, Cat. No. 760-700). Each step is incubated for a selectable time and temperature. At the end of each incubation step, the VENTANA BenchMark ULTRA instrument washes the sections to remove unbound material that would hinder the desired reaction in subsequent steps and applies a liquid coverslip (Cat. No. 650-210), which minimizes the evaporation of the aqueous reagents from the slide. en