INTRODUCTION: HER2, also known as epidermal growth factor receptor 2, neu, ERBB2 or CD340 is a proto-oncogene located in the human chromosome 17, band 21 that code a transmembrane glycoprotein (p185) with tyrosine-kinase activity. Because of its interaction and similarity to EGFR and other members of the epidermal growth factor receptor family, HER2 takes part in the differentiation of some cell-lines during embryogenesis after the interaction between mesenchyme–epithelium-neuroectoderm. It also has an influence on the migration, differentiation and interaction between numerous cells.
The overexpression of HER2 has been proven in over 20% of adenocarcinomas of different locations, including lung, uterus, gastrointestinal and urinary tract, breast and skin appendages in different studies. In case of breast and stomach cancers, the overexpression of this oncoprotein, which is associated with a worse prognosis, is related to the gene amplification and it is subsidiary of responding to treatment anti HER2 with Trastuzumab (Herceptin), the humanized monoclonal antibody able to block this growth receptor and for which purpose, similar results have been obtained in malignant neoplasias, such as ovarian, stomach and salivary gland carcinomas.
INTENDED USE: The HER2 FISH probe is designed to detect the number of copies of the gen ERBB2 (Her2/neu) in the 17q12 chromosome region. The probe CEN17 is designed to detect an alpha-satellite sequence of DNA located in the 17p11.1 region and allows identifying and counting the number of copies of chromosome 17.
PROBE DESCRIPTION: The Her2 FISH Probe labeled with the CytoOrange fluorochrome covers a chromosomal region which includes the entire ERBB2 gene. The CCP17 FISH Probe labeled with the CytoGreen fluorochrome is covering the alpha satellite region of the centromere of the chromosome 17 and is designed as a control to determine the number of copies per cell of the chromosome 17.