LSI Her-2/neu (Orange)/CEP 17 (Green)

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Probe location


Probe description

The Her-2/neu FISH kit is intended for the determination of Her-2/neu gene amplification in human tissues using fluorescence in situ hybridization (FISH).
The Her-2/neu FISH kit is CE marked and can be used for in vitro diagnostic tests.
The Her-2/neu FISH kit contains two directly labeled fluorescent DNA probes in hybridization buffer. The fluorochrome Orange labeled Her-2/neu probe covers the chromosome 17q11-12 region. The fluorochrome Green labeled chromosome enumeration CEP17 probe covers the chromosome 17p11.1-q11.1 region.


The Her-2/neu (Human Epidermal Growth Factor Receptor 2 also known as Neu) gene codes for a 185 kDa transmembrane receptor with tyrosine kinase activity and belongs to the EGF (epidermal growth factor) receptor family. Her-2/neu gene is amplified in 15-30% of breast cancer, and less frequently in other cancers, e. g. lung, pancreatic, ovarian, or stomach cancesr. The Her-2/neu gene amplification is strongly associated with increased disease recurrence and worse prognosis. Breast cancer patients with Her-2/neu gene amplification are treated with monoclonal antibody p185Her-2 trastuzumab (Herceptin) and/or tyrosin kinase inhibitors (lapatinib, Tyverb).

FISH results

The copy number of Her-2/neu and CEP17 is evaluated in at least 100 cell nuclei in histologically verified section of tissue.

Evaluation of positivity / negativity is carried out according to current recommendations ASCO / CAP.

Normally observed in cell two orange signals (Her2/neu) and two green signals (chromosome 17) (Fig. 1a). Figure 1b shows the polyploidy of chromosome 17, accompanied by a higher copy number of Her2/neu gene (pseudo-amplification). True amplification, i.e. a higher number of Her2/neu gene copies with a normal number of chromosome 17, is shown in figure 1c.

A normal cell in FFPE tissue hybridized with LSI Her-2/neu (Orange)/CEP17 (Green) shows 2 orange signals of Her-2/neu gene and 2 green signals of chromosome 17. An abnormal cell in FFPE tissue hybridized with LSI Her-2/neu (Orange)/CEP17 (Green) shows the polyploidy of chromosome 17 and a higher copy number of Her2/neu gene (pseudo-amplification). An abnormal cell in FFPE tissue hybridized with the LSI LSI Her-2/neu (Orange)/CEP17 (Green) shows 2 green signals of chromosome 17 and higher copy number of Her2/neu gene (amplification).
1a 1b 1c

Figure 1: Assessment of the copy number of Her-2/neu gene and the copy number of chromosome 17 on FFPE (breast cancer patient tissue).    
red LSI Her-2/neu 
green CEP17
a) Two copies of Her-2/neu genes as well as chromosome 17 in cell (physiological finding).
b) Polyploidia of chromosome 17 with a higher copy number of Her-2/neu gene (pseudo-amplification).
c) Normal copy number of chromosome 17, higher copy number of Her-2/neu gene (true amplification).



Catalogue number

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Instruction for use

LSI Her-2/neu (Orange)/CEP17 (Green) 



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