HER2/neu

This gene encodes a member of the epidermal growth factor (EGF) receptor family of receptor tyrosine kinases. This protein has no ligand binding domain of its own and therefore cannot bind growth factors. However, it does bind tightly to other ligand-bound EGF receptor family members to form a heterodimer, stabilizing ligand binding and enhancing kinase-mediated activation of downstream signalling pathways, such as those involving mitogen-activated protein kinase and phosphatidylinositol-3 kinase. Allelic variations at amino acid positions 654 and 655 of isoform a (positions 624 and 625 of isoform b) have been reported, with the most common allele, Ile654/Ile655, shown here. Amplification and/or overexpression of this gene has been reported in numerous cancers, including breast and ovarian tumors. Alternative splicing results in several additional transcript variants, some encoding different isoforms and others that have not been fully characterized.

Reference: http://www.ncbi.nlm.nih.gov/gene/2064

Assay type: Immunohistochemistry (IHC)
What is analyzed: Semi-quantitative detection of Human Epidermal Growth Factor Receptor 2 (HER2/neu)
Platform: Dako Autostainer  Plus & Autostainer Link
Kit/antibody: HercepTest™ (Dako)
Tissue Type: Gastric, Breast and Lung carcinoma
Required material: FFPE tissue

Assay type: Fluorescence in situ hybridization (FISH)
What is analyzed: Human Epidermal Growth Factor Receptor 2 (HER2/neu) amplification
Platform: Hybridizer (Dako), Thermobrite (Abbott Molecular)
Kit/Probe: HER2 FISH pharmDx™ Kit (Dako)
Tissue Type: Gastric, Breast, Lung carcinoma
Required material: FFPE tissue

Assay type: Brightfield dual in situ hybridization (bdISH)
What is analyzed: Human Epidermal Growth Factor Receptor 2 (HER2/neu) amplification
Platform: VENTANA BenchMark® XT and ULTRA
Kit/antibody: INFORM HER2 Dual ISH DNA Probe Cocktail (Ventana)
Tissue Type: Gastric, Breast, Lung carcinoma
Required material: FFPE tissue
Reference: Bang YJ et al., Lancet. (2010) 28;376(9742):687-97

Assay type: Immunohistochemistry (IHC)
What is analyzed: Semi-quantitative detection of Human Epidermal Growth Factor Receptor 2 (HER2/neu)
Platform: VENTANA BenchMark® XT and ULTRA
Kit/antibody: Pathway® HER2 (4B5) Kit
Tissue Type: Gastric, Breast, Lung and Ovarian carcinoma
Required material: FFPE tissue

Assay type: Fluorescence in situ hybridization (FISH)
What is analyzed: Human epidermal growth factor receptor 2 (HER2/neu) amplification
Platform: Hybridizer (Dako), Thermobrite (Abbott Molecular)
Kit/Probe:  PathVysion (Abbott Molecular)
Tissue Type: Gastric, Breast carcinoma
Required material: FFPE tissue

Assay type: ELISA
What is analyzed: Quantitative determination of circulating HER2/neu extracellular domain fragments
Kit/antibody: Wilex/Oncogene HER2/neu ELISA kit
Required material: Human blood serum