HER-2 Gene Amplification Analysis Kit

HER-2 Gene Amplification Analysis Kit

  • Item No :ADx-FHE03
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HER-2 Gene Amplification Analysis Kit

    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™.


    Intended Use:

    The kit is a qualitative test to accurately identify HER-2 gene amplification and over-expression via fluorescence in situhybridization (FISH) technology. The used specimen is formalin-fixed paraffin-embedded (FFPE) tissue of breast and gastric cancers.


    Technological Principles:

    The kit usesfluorescence in situhybridization (FISH) technology, which employs a dual-colorHER-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 counterstain 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.


    Kit Design: HER-2/CSP17Dual color probes

    Equipment requirement:

    Fluorescence microscope with Cy3 (orange signal with excitation wavelength 550nm and emission wavelength 575nm) and FITC (green signal with excitation wavelength 494nm and emission wavelength 519nm) filters.


    Experimental Procedure:

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AmoyDx®HER-2 Gene Amplification Analysis Kit





(In dark condition)

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