title: Simultaneous analysis of HER2 gene and protein on a single slide facilitates HER2 testing of breast and gastric carcinomas.
abstract: This study sought to evaluate a new combined gene and protein detection platform in the context of HER2 evaluation in breast and gastric carcinomas. HER2 immunohistochemistry (IHC) and dual color in situ hybridization (Dual ISH) were combined on a single slide. Results were compared with conventional HER2 IHC and fluorescence ISH. Results from the gene and protein assay were reliable and highly reproducible for both breast and gastric carcinomas. Concordance was found between conventional HER2 IHC and ISH testing and the gene and protein assay in the same laboratory (>95% for Dual ISH; lower for IHC because of different antibody clones), between IHC and Dual ISH performed on the same slide (>92%), and in the gene and protein assays between laboratories (>96%). This cost- and time-effective method provides fast and definitive results (IHC confirmed by means of Dual ISH) to aid in rapid treatment decisions. It can also be applied to other gene and protein combinations.
authors.affiliation: Institute of Pathology, Lucerne Cantonal Hospital, Lucerne, Switzerland.
authors.forename: Astrid
authors.initials: A
authors.lastname: Hirschmann
authors.forename: Tiffany Ann
authors.initials: TA
authors.lastname: Lamb
authors.forename: Georges
authors.initials: G
authors.lastname: Marchal
authors.forename: Mary
authors.initials: M
authors.lastname: Padilla
authors.forename: Joachim
authors.initials: J
authors.lastname: Diebold
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000235:genetics / Q000378:metabolism; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000378:metabolism; D005260:Female; D018734:Genes, erbB-2 / Q000235:genetics* / Q000276:immunology; D006801:Humans; D007150:Immunohistochemistry; D017403:In Situ Hybridization / Q000379:methods; D017404:In Situ Hybridization, Fluorescence / Q000379:methods; D051379:Mice; D011237:Predictive Value of Tests; D011817:Rabbits; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis* / Q000235:genetics / Q000276:immunology / Q000378:metabolism; D013274:Stomach Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000378:metabolism
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D018719:Erb-b2 Receptor Tyrosine Kinases