VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx - Immunohistology cell marker IVDs

Intended purpose

VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx is intended for the semi-quantitative detection of HER2 protein by immunohistochemistry (IHC) in sections of formalin-fixed, paraffin-embedded breast and gastric carcinoma 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, pertuzumab, trastuzumab emtansine, or trastuzumab deruxtecan. Additionally, this IHC device is indicated as an aid in the assessment of gastric cancer patients for whom trastuzumab treatment is being considered.

Functional description

Immunohistochemical staining of tissues for HER-2 antigen as an aid in identifying patients eligible for treatment with nominated therapies in selected indications.