Ventana VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx

VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx is intended for the semi-quantitative detection of HER2 antigen by immuno-histochemistry (IHC) in sections of formalin-fixed, paraffin-embedded breast and gastric tissue stained on a BenchMark IHC/ISH instrument. This IHC device is indicated for identifying breast cancer patients who are eligible for treatment with trastuzumab (IHC 3+ or IHC 2+/ISH amplified), pertuzumab (IHC 3+ or IHC 2+/ISH amplified), trastuzumab emtansine (IHC 3+ or IHC 2+/ISH amplified), or fam-trastuzumab deruxtecan-nxki (IHC 1+ or IHC 2+/ISH non-amplified). Additionally, this IHC device is indicated as an aid in the assessment of gastric cancer patients for whom trastuzumab treatment is being considered (IHC 3+ or IHC 2+/ISH amplified). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.