For in vitro diagnostic use. Membrane Others VENTANA CLDN18 43-14A RxDx Assay CE IVD Gastric intestinal metaplasia (positive) VENTANA® CLDN18 (43-14A) RxDx Assay PID00000802 CE-IVD Mouse 43-14A VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohisto- chemical assay using mouse monoclonal anti-claudin 18, clone 43-14A, intended for laboratory use in the assessment of claudin 18 (CLDN18) protein in formalin-fixed, paraffin- embedded (FFPE) gastric adenocarcinoma including gastroesophageal junction (GEJ) tissue specimens by light microscopy. This assay is used with OptiView DAB IHC Detection Kit for staining on a BenchMark IHC/ISH instrument.The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY® (zolbetuximab) in accordance with the approved therapeutic product labeling. The clinical cut- off is ≥75% tumor cells (%TC) demonstrating moderate to strong membrane CLDN18 staining above background.Test results of the VENTANA CLDN18 (43-14A) RxDx Assay 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. en VENTANA CLDN18 (43-14A) RxDx Assayis a mouse monoclonal primary antibody which binds to CLDN18 protein in FFPE tissue sections. The specific antibody can be located by using OptiView DAB IHC Detection Kit. Refer to the OptiView DAB IHC Detection Kit method sheet for further information. en