title: Determination of HER2 amplification in primary breast cancer using dual-colour chromogenic in situ hybridization is comparable to fluorescence in situ hybridization: a European multicentre study involving 168 specimens.
abstract: OBJECTIVE
  Fluorescence in situ hybridization (FISH) can be used to reveal several genomic imbalances relevant to proper cancer diagnosis and to the correct treatment regime. However, FISH requires expensive and advanced fluorescence microscopes in addition to expertise in fluorescence microscopy. To determine whether a newly developed dual-colour chromogenic in situ hybridization (CISH) method is a suitable alternative to FISH, we analysed the human epidermal growth factor receptor 2 gene (HER2) amplification level of 168 breast cancer specimens using dual-colour CISH and FISH and compared the results.
  
  
  RESULTS
  We found 100% agreement between HER2 status determined by FISH and dual-colour CISH. Furthermore, we observed that the time used to score slides was significantly reduced by 28% in dual-colour CISH compared with the FISH protocol. Concordance between HER2 protein status and dual-colour CISH or FISH was equally good with an overall agreement of 96.8%. Correlation between the HER2/centromere 17 gene ratios obtained with dual-colour CISH and FISH was highly significant with an overall correlation coefficient (rho) of 0.96.
  
  
  CONCLUSIONS
  We conclude that dual-colour CISH and bright field microscopy are excellent alternatives to FISH when analysing the HER2 status of primary breast cancer.
authors.affiliation: Department of Morphological Sciences, School of Medicine-University Clinical Hospital, University of Santiago de Compostela, Santiago de Compostela, Spain.
authors.forename: Tomás
authors.initials: T
authors.lastname: García-Caballero
authors.forename: Dorthe
authors.initials: D
authors.lastname: Grabau
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Green
authors.forename: John
authors.initials: J
authors.lastname: Gregory
authors.forename: Arno
authors.initials: A
authors.lastname: Schad
authors.forename: Elke
authors.initials: E
authors.lastname: Kohlwes
authors.forename: Ian O
authors.initials: IO
authors.lastname: Ellis
authors.forename: Sarah
authors.initials: S
authors.lastname: Watts
authors.forename: Jens
authors.initials: J
authors.lastname: Mollerup
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000378:metabolism; D002503:Centromere / Q000737:chemistry / Q000378:metabolism; D003116:Color; D005060:Europe; D005260:Female; D005784:Gene Amplification / Q000235:genetics; D018734:Genes, erbB-2; D006801:Humans; D006824:Hybridization, Genetic; D017403:In Situ Hybridization / Q000379:methods*; D017404:In Situ Hybridization, Fluorescence; D008853:Microscopy; D008856:Microscopy, Fluorescence; D009369:Neoplasms / Q000235:genetics
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