title: Assessment of HER2 amplification status in breast cancer using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay.
abstract: In breast cancer the human epidermal growth factor receptor 2 (HER2) is an important target for a number of different HER2 inhibitors. Different slide-based assays are available for assessment of treatment eligibility, which include fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods for assessment of the HER2 gene status. Here we report a summary of the validation data on HER2 IQFISH pharmDx™ (Dako Omnis), a newly developed assay for the automated staining platform Dako Omnis. The assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of 3½ to 4h from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary covers method comparison, assessment of staining quality, observer-to-observer reproducibility as well as reproducibility within and between laboratories. Based on data from the different studies it was concluded that HER2 IQFISH pharmDx (Dako Omnis) is a reliable and robust assay with a high precision that is at least comparable to the manual HER2 IQFISH pharmDx™ assay and the PathVysion(®)HER-2 DNA Probe Kit.
authors.affiliation: University of Milan, Istituto Europeo di Oncologia, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.affiliation: UCL Advanced Diagnostics, London, UK.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Paterson
authors.affiliation: Clarient Pathology Services, Aliso Viejo, CA, USA.
authors.forename: Miriam
authors.initials: M
authors.lastname: Bloch
authors.affiliation: Clarient Pathology Services, Aliso Viejo, CA, USA.
authors.forename: George
authors.initials: G
authors.lastname: Csathy
authors.affiliation: UCL Advanced Diagnostics, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Allen
authors.affiliation: University of Milan, Istituto Europeo di Oncologia, Milan, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Dell'Orto
authors.affiliation: Dako, An Agilent Technologies Company, Glostrup, Denmark.
authors.forename: Gitte
authors.initials: G
authors.lastname: Kjærsgaard
authors.affiliation: Dako, An Agilent Technologies Company, Glostrup, Denmark.
authors.forename: Yaron Y
authors.initials: YY
authors.lastname: Levy
authors.affiliation: Dx-Rx Institute, Baunevaenget 76, DK-3480 Fredensborg, Denmark. Electronic address: jan.trost@dx-rx.dk.
authors.forename: Jan Trøst
authors.initials: JT
authors.lastname: Jørgensen
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics* / Q000378:metabolism / Q000473:pathology; D005260:Female; D005784:Gene Amplification; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods / Q000592:standards*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics* / Q000378:metabolism; D015203:Reproducibility of Results
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: Automation; Breast cancer; Companion diagnostic; HER2; IQFISH