Statistical Methods for Biotechnology Products－Part II: Biochip Diagnostic Products Examples of Regulatory Evaluation of Biochip Products

Abstract

HER2 (the human epidermal growth factor receptor 2) is a member of the HER (erbB) family of transmembrane tyrosine kinase Enhanced level of HER2 is associated with mammary epithelial cell transformation and shorter survival in patients with breast cancer  25% of invasive breast cancers exhibit HER2 gene amplification The rate of HER2 gene amplification or protein in ductal carcinoma in situ (DCIS) is higher than invasive cancer  pathogenic role in the initiation of mammary carcinoma Treatment of Herceptin - requirement of screening the patients with over-expressed HER2 level