Amplification Probe

Order Number
Package Size
100 µl (10 Tests)
Regulatory Status

IVDR Certification

MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.

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Product Description


XL ERBB2 (HER2/NEU) amp consists of an orange-labeled probe hybridizing to the ERBB2 (HER2/NEU) gene region at 17q12 and a green-labeled probe hybridizing to the centromere of chromosome 17.

Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.

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Clinical Details

Amplification or over-expression of the ERBB2 (HER2/NEU) gene occurs in approximately 15-30% of breast cancers. It is strongly associated with increased disease recurrence and a poor prognosis. Over-expression is also known to occur in ovarian, stomach, and aggressive forms of uterine cancer, such as uterine serous endometrial carcinoma.
ERBB2, located on the long arm of human chromosome 17 (17q12), is a member of the epidermal growth factor receptor (EGFR/ErbB) family which is composed of four plasma membrane-bound receptor tyrosine kinases. Signaling through the ErbB family of receptors promotes cell proliferation and opposes apoptosis.
ERBB2 is the target of the monoclonal antibody trastuzumab (marketed as Herceptin®).

Clinical Applications

  • Solid Tumors (Solid Tumors)
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XL ERBB2 (HER2/NEU) amp hybridized on breast cancer tissue. Multiple orange signals indicate amplification of ERBB2 (HER2/NEU).

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell (typical results):
Two green (2G) and one separate orange (1O) signal, and orange signal clusters indicating amplification of ERBB2 (HER2/NEU) (homogeneously staining region =HSR)..

Expected Pattern 3

Aberrant Cell (typical results):
Two green (2G) and multiple copies of orange signals indicating amplification of ERBB2 (HER2/NEU) (double minute=dm).

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  • Isola et al (1999) Clin Cancer Res 5:4140-4145
  • Blancato et al (2004) Br J Cancer 90:1612-1619
  • Singhi et al (2012) Mod Pathol 25:378-387



IVDR Certification

MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.

IVDR Certification