title: Chromogenic in situ hybridization is a reliable method for detecting HER2 gene status in breast cancer: a multicenter study using conventional scoring criteria and the new ASCO/CAP recommendations.
abstract: Chromogenic in situ hybridization (CISH) has shown the potential to replace fluorescence in situ hybridization (FISH) to determine HER2 gene status. To validate the reliability of CISH, we used 226 consecutive breast carcinomas from 2 institutions and tested CISH and FISH on the same tumor set simultaneously at different test sites. Besides manufacturers' scoring criteria, the new American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines were used to interpret HER2 status. The concordance between CISH and FISH for positive and negative results was 98.5% at site A and 98.6% at site B using the manufacturers' criteria, and 99.0% at site A and 99.1% at site B using the ASCO/CAP criteria. Reproducibility of CISH results was more than 98.0% among 3 sites using the manufacturers' criteria and 100.0% between 2 sites using the ASCO/CAP criteria. Our results confirm that CISH is reliable for HER2 testing per ASCO/CAP guidelines.
authors.affiliation: Department of Pathology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.
authors.forename: Yun
authors.initials: Y
authors.lastname: Gong
authors.forename: William
authors.initials: W
authors.lastname: Sweet
authors.forename: Yi-Jing
authors.initials: YJ
authors.lastname: Duh
authors.forename: Larry
authors.initials: L
authors.lastname: Greenfield
authors.forename: Yuan
authors.initials: Y
authors.lastname: Fang
authors.forename: Jianxin
authors.initials: J
authors.lastname: Zhao
authors.forename: Emily
authors.initials: E
authors.lastname: Tarco
authors.forename: W Fraser
authors.initials: WF
authors.lastname: Symmans
authors.forename: Jorma
authors.initials: J
authors.lastname: Isola
authors.forename: Nour
authors.initials: N
authors.lastname: Sneige
mesh_terms: D001943:Breast Neoplasms / Q000235:genetics*; D002863:Chromogenic Compounds; D005260:Female; D018734:Genes, erbB-2; D017408:Guidelines as Topic; D006801:Humans; D017403:In Situ Hybridization / Q000379:methods*; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D002863:Chromogenic Compounds