Oncotype DX® - Genomic Health (Redwood City, California)
Reverse transcription polymerase chain reaction (RT-PCR) based assay analyzes the expression of a panel of 21 genes, among them HER2.
HERmark® Breast Cancer Assay - Monogram Biosciences (San Francisco, California)
This assay provides direct quantitative measurements of HER2 total protein and HER2 homodimer levels in formalin-fixed paraffin-embedded (FFPE) tissue.
HER2/neu Enzyme-linked immunosorbent assay (ELISA) - Siemens Healthcare Diagnostics (Erlangen, Germany)
FDA approved "sandwich" enzyme immunoassay using mouse monoclonal antibody for capture and a different biotinylated mouse monoclonal antibody for the detection of human HER2 protein.