HER2 Quantitative Antigen Assay Test Kit - Vietnam Registration 2401163ĐKLH/BYT-HTTB

PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) of Ventana Medical Systems, Inc. (Ventana) is a rabbit monoclonal antibody used in the laboratory to detect the quantitative amount of HER2 antigen on normal tissue sections and formalin-fixed, paraffin-embedded cancer tissue sections, and subsequently stained on the BenchMark IHC/ISH. The test is indicated to support the evaluation of breast cancer patients who are being considered for treatment with Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine). This product must be interpreted by a pathologist with combined expertise in histology and clinical information, and appropriate control material. The antibody is intended for in vitro diagnostic use (IVD). Note: All patients in the Herceptin clinical trials were selected using a clinical trial assay. No patients in these trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY anti-HER-2/neu (4B5) was compared to PATHWAY HER-2 (clone CB11) Primary Antibody on an independent test panel and yielded acceptable concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcomes has not been established.