title: Analysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay.
abstract: The human epidermal growth factor receptor 2 (HER2) is an important target for treatment of gastroesophageal cancer. Different slide-based assays are available for assessment of HER2 status. Overexpression of the HER2 protein is assessed by immunohistochemistry (IHC) whereas amplification of the HER2 gene is assessed by fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods. 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. This assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of less than 4 hours from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary cover 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 high precision and at least comparable to the manual HER2 IQFISH pharmDx™ assay. The HER2 IQFISH pharmDx (Dako Omnis) assay is currently not commercially available outside the Europe Union.
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, Fredensborg, Denmark. jan.trost@dx-rx.dk.
authors.forename: Jan Trøst
authors.initials: JT
authors.lastname: Jørgensen
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis; D004943:Esophagogastric Junction / Q000473:pathology*; D020869:Gene Expression Profiling / Q000379:methods*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods*; D015588:Observer Variation; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D015203:Reproducibility of Results; D013274:Stomach Neoplasms / Q000473:pathology*
chemical_list: D014408:Biomarkers, Tumor; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human