Product Details
The human HER2 gene (also known as ERBB2 or NEU) encodes a protein often referred to as HER2 protein or p185HER2. The HER2 protein is a membrane receptor tyrosine kinase with homology to the epidermal growth factor receptor (EGFR or HER1). The HER2 protein is a normal component expressed by a variety of epithelial cell types.
In a fraction of patients with breast cancer, the HER2 protein is overexpressed as part of the process of malignant transformation and tumour progression. Overexpression of the HER2 protein on the surface of breast cancer cells suggested that it could be a target for an antibody therapeutic. Herceptin® (trastuzumab) is a humanized monoclonal antibody (10) that binds with high affinity to the HER2 protein and has been shown to inhibit the proliferation of human tumour cells that overexpress HER2 protein in vitro and in vivo.
HercepTest™ is developed to provide an alternative to the investigational CTA used in the Herceptin® clinical studies. The performance of HercepTest™ for the determination of HER2 protein overexpression was evaluated in an independent study comparing the results of the HercepTest™ to the CTA on 548 breast tumour specimens, none of which were obtained from patients in the Herceptin® clinical studies. The results indicated a 79% concordance between the results from the two assays on these tissue specimens.
For in vitro diagnostic use.
HercepTest™ is a semi-quantitative immunocytochemical assay to determine HER2 protein overexpression in breast cancer tissues are routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma.
HercepTest™ is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered for breast cancer patients for whom PERJETA™ (pertuzumab) or KADCYLATM (ado-trastuzumab emtansine) treatment is being considered (see Herceptin®, PERJETA™ and KADCYLATM package inserts).