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XL ERBB2 (HER2/NEU) amp
Amplification Probe
- Order Number
- D-6010-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1717
- Regulatory Status
- IVDD
IVDR Certification
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
Discover all IVDR-certified products
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 for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
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)

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

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)..

Aberrant Cell (typical results):
Two green (2G) and multiple copies of orange signals indicating amplification of ERBB2 (HER2/NEU) (double minute=dm).
- 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
Certificate of Analysis (CoA)
or go to CoA Database