BREAST CANCER
CAT.# FP-001: HER2 GENE AMPLIFICATION PROBE
IVD/RUO
BACKGROUND
Human epidermal growth factor receptor 2 (HER2, also known as ERBB2, Neu, ErbB-2, CD340 or p185) is a proto-oncogene HER2/neu located on the long arm 17q12 of human chromosome 17. The coding, which is a member of the epidermal growth factor receptor (EGFR/ErbB) family, has tyrosine kinase activity and is involved in signal transduction of cell growth and differentiation. The oncogenic mechanism of the HER2 oncogene includes inhibition of apoptosis, promotion of cell proliferation, increase of invasiveness of tumor cells, and promotion of tumor vascular and lymphangiogenesis. 20% of breast cancer and 12% of gastric cancer patients showed positive HER2 gene amplification.
PROBE DESCRIPTION
The HER2 gene amplification probe uses the orange-red dye to label the HER2 gene region and the green dye is used to label the chromosome 17 centromere region (CEP17). The HER2 gene marker region is located at 17q12-q21.1, and the CEP17 probe adopts an alpha satellite sequence, which has extremely high specificity and does not hybridize with other chromosome centromeres to produce noisy spots.
CLINICAL SIGNIFICANCE
Fluorescence in situ hybridization (FISH) is a clinicaly recognized ” gold standard ” for HER2 detection. It can accurately and repeatedly evaluate the status of HER2 gene in cancer cells. Compared with IHC, FISH has higher consistency. The patients with positive HER2 gene amplification were effectively treated with targeted drugs such as monoclonal antibodies herceptin and lapatinib. The prognosis of patients with positive HER2 gene amplification was poor, and the disease-free survival and overall survival were significantly shortened.
References
- Sauter G, et al. J Clin Oncol 27:1323-1333, 2009.
- Mass R, et al. Clinical Breast Cancer, Vol 6, No.3, 240-246,2005.
- Allison M, Nature Biotechnology 28 (2): 117-119, 2010.
- Press m, et al, Clinical Cancer Research 2005; 11(18) September 15, 2005