Accurate breast cancer diagnosis through real-time PCR her-2 gene quantification using immunohistochemically-identified biopsies.

her-2 gene amplification and its overexpression in breast cancer cells is directly associated with aggressive clinical behavior. The her-2 gene and its Her-2 protein have been utilized for disease diagnosis and as a predictive marker for treatment response to the antibody herceptin. Fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC) are the most common FDA-approved methodologies involving gene and protein quantification, respectively. False positive or negative her-2/Her-2 patient results may result in inappropriate treatment administration. To support accurate quantification and interpretation of results, in this study we have standardized qPCR analysis using previously identified IHC samples, obtaining very significant and clinically useful results.