AmoyDx® HER-2 Gene Amplification Analysis Kit | 8.03.25101X020G

AmoyDx® HER-2 Gene Amplification Analysis Kit | 8.03.25101X020G | Gentaur UK, US & Europe Distribution

FISH assay for detection of HER-2 gene amplification and over-expression

The proto-oncogeneHER-2 gene (also called ERBB2 or HER2/neu) is a member of the human epidermal growth factor receptor (HER/EGFR/ERBB) family, which is locatedat the long arm of human chromosome 17 (17q12-q21).HER-2 geneencodes a 185-kDa HER-2 protein, which is a membrane receptor tyrosinekinase with homology to EGFR(HER-1).

Amplification or over-expression of HER-2 gene has been shown to play an important role in the development and progression of several aggressive types of human cancers, which occurs in 20-30% of breast cancer, approx. 20% of gastric cancer, also prostate, ovarian cancer and uterine serous endometrial carcinoma.

Demonstration of HER-2 gene amplification or over-expression is essential for initiating therapy with HER-2 targeted therapy, such as Herceptin™, a monoclonal antibody to HER-2 protein. Clinical studies have shown that patients whose tumors have high HER-2 gene amplification or over-expression benefit most from Herceptin™.

Technological Principles

The kit uses fluorescence in situ hybridization (FISH) technology, which employs a dual-color HER-2/CSP17 FISH probe with two fluorescent-labeled DNA probes to detect HER-2 gene amplification and over-expression.The tissue specimens were handled with a series of pre-treatment procedures, and the targeted DNA is denatured to single-stranded form and hybridized with the FISH probes. Following a series of wash and counter stain steps, the hybridization of the probes is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, then the HER-2/CSP17 ratio is calculated.