title: HER-2/neu diagnostics in breast cancer.
abstract: HER-2/neu status of the primary breast cancer (PBC) is determined by immunohistochemistry and fluorescent in situ hybridization. Because of a variety of technical factors, however, the PBC may not accurately reflect the metastatic tumor in terms of HER-2/neu status. Recently published guidelines recommend that tumors be defined as HER-2/neu positive if 30% or more of the cells are 3+. Circulating levels of the HER-2 extracellular domain can be measured in serum using a test cleared by the US Food and Drug Administration, and increased serum HER-2/neu levels to above 15 ng/ml can reflect tumor progression. Studies comparing tissue HER-2/neu status of the PBC and HER-2/neu levels above 15 ng/ml in metastatic breast cancer patients are also reviewed.
authors.affiliation: Oncogene Science, Siemens Medical Solutions Diagnostics, Rogers Street, Cambridge, Massachusetts 02142, USA. walter.carney@siemens.com
authors.forename: Walter P
authors.initials: WP
authors.lastname: Carney
authors.forename: Kim
authors.initials: K
authors.lastname: Leitzel
authors.forename: Suhail
authors.initials: S
authors.lastname: Ali
authors.forename: Rainer
authors.initials: R
authors.lastname: Neumann
authors.forename: Allan
authors.initials: A
authors.lastname: Lipton
mesh_terms: D014408:Biomarkers, Tumor; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology; D005260:Female; D014644:Genetic Variation; D006801:Humans; D017403:In Situ Hybridization; D017404:In Situ Hybridization, Fluorescence; D009362:Neoplasm Metastasis / Q000235:genetics / Q000473:pathology; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis / Q000097:blood / Q000235:genetics*
chemical_list: D014408:Biomarkers, Tumor; D018719:Erb-b2 Receptor Tyrosine Kinases