Immunohistology cell marker IVDs

Intended purpose

HercepTest™ is a semi-quantitative immunocytochemical assay to determine HER2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with adenocarcinoma of the stomach including gastroesophageal junction. HercepTest™ is indicated as an aid in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered (see Herceptin™ package insert).