All of the following are FDA approved IHC testing methods for HER2:
HercepTest™ - Dako North America (Carpinteria, California)
Semi-quantitative IHC assay for the determination of HER2 protein overexpression in breast cancer tissues routinely processed for histological evaluation. The HercepTest™, developed by Dako Cytomation, uses the Dako Cytomation Autostainer and consists of ready to use reagents. It is a two-step IHC procedure for routinely processed, formalin-fixed, paraffin embedded (FFPE) tissue specimens. Dako was the first company to offer an FDA approved testing kit and is/was considered the 'gold standard'. The c-erbB-2 antibody is a rabbit polyclonal product.
InSite™ HER2/neu CB11 - Biogenex (San Ramon, California)
IHC assay using a monoclonal antibody directed against the internal domain of HER2.
Pathway anti-HER2/neu (Clone CB11) - Ventana Medical Systems (Oro Valley, Arizona)
Semi-quantitative IHC assay using a monoclonal antibody for the detection of c-erbB2 (HER2) antigen
