All of the following are FDA-approved immunohistochemistry (IHC) testing methods for HER2:
HercepTest™ - Agilent Dako (Santa Clara, California)
A semi-quantitative IHC assay for determining HER2 protein overexpression in breast cancer tissues is routinely processed for histological evaluation. The HercepTest™, developed by Dako Cytomation, can be used on Agilent Dako automated staining platforms and consists of ready-to-use reagents. It is a two-step IHC procedure for routinely processed, formalin-fixed paraffin-embedded (FFPE) tissue specimens. Agilent Dako was the first company to offer an FDA-approved testing kit, which is/was considered the 'gold standard.' The c-erbB-2 antibody is a rabbit polyclonal product.
Bond Oracle HER2 IHC System™ - Leica Biosystems (Buffalo Grove, Illinois)
A semi-quantitative IHC assay that uses a mouse monoclonal antibody to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in formalin-fixed paraffin-embedded breast cancer tissue processed for histological evaluation following automated staining on Leica BOND automated slide staining instruments. The antibody is directed against the internal domain of the HER2 oncoprotein.
Pathway anti-HER2/neu (Clone 4B5)™ - Ventana Medical Systems of ROCHE Diagnostics (Indianapolis, Indiana)
A semi-quantitative IHC assay using a rabbit monoclonal antibody directed against the internal domain of the c-erbB-2 oncoprotein (HER2) in sections of formalin-fixed paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining instrument.
