title: Comparison of dual-color dual-hapten brightfield in situ hybridization (DDISH) and fluorescence in situ hybridization in breast cancer HER2 assessment.
abstract: The most optimal method for assessing HER2 status is still subject to controversy as far as the type of assay used, the optimal method to perform, and the costs of each assay are concerned. The current study was done as a validation study prior to setting up a clinical HER2 testing service using the new commercial dual-color dual-hapten brightfield in situ hybridization (DDISH), but it was felt that our experience may be of interest to other laboratories considering setting up HER2 diagnostic facilities. One hundred and five patients diagnosed with invasive breast cancer were selected. PathVysion FISH and DDISH assays were carried out. Concordance correlation coefficients showed near perfect agreement in average HER2 and centromere-specific signal counts per cell and in HER2/CEN17 ratios between the PathVysion and the DDISH assays, and also the Kappa measure showed near perfect agreement between the two assays (Kappa=0.8712, P<0.0001). Statistical analysis confirmed that the two assays are comparable in terms of detection of HER2 gene amplification and suggests its utilization in routine HER2 diagnostics.
authors: Department of Surgery, Medical and Health Science Center, University of Debrecen, Nagyerdei krt 98, H-4012 Debrecen, Hungary.
authors: Csaba
authors: C
authors: Kosa
authors: Laszlo
authors: L
authors: Kardos
authors: Judit
authors: J
authors: Kovacs
authors: Zoltan
authors: Z
authors: Szollosi
mesh_terms: D001943:Breast Neoplasms / Q000235:genetics* / Q000378:metabolism; D005260:Female; D006241:Haptens; D006801:Humans; D017403:In Situ Hybridization / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D006241:Haptens; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human