title: An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines.
abstract: Immunohistochemistry (IHC) is used as the frontline assay to determine HER2 status in invasive breast cancer patients. The aim of the study was to compare the performance of the Leica Oracle HER2 Bond IHC System (Oracle) with the current most readily accepted Dako HercepTest (HercepTest), using both commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. A total of 445 breast cancer samples from 3 international clinical HER2 referral centers were stained with the 2 test systems and scored in a blinded fashion by experienced pathologists. The overall agreement between the 2 tests in a 3×3 (negative, equivocal and positive) analysis shows a concordance of 86.7% and 86.3%, respectively when analyzed using commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. There is a good concordance between the Oracle and the HercepTest. The advantages of a complete fully automated test such as the Oracle include standardization of key analytical factors and improved turn around time. The implementation of the modified ASCO/CAP and UK HER2 IHC scoring guidelines has minimal effect on either assay interpretation, showing that Oracle can be used as a methodology for accurately determining HER2 IHC status in formalin fixed, paraffin-embedded breast cancer tissue.
authors.affiliation: Department of Pathology, R.C.S.I. Education & Research Centre, Beaumont Hospital, Dublin 9, Ireland. togrady@rcsi.ie
authors.forename: Anthony
authors.initials: A
authors.lastname: O'Grady
authors.forename: David
authors.initials: D
authors.lastname: Allen
authors.forename: Lisa
authors.initials: L
authors.lastname: Happerfield
authors.forename: Nicola
authors.initials: N
authors.lastname: Johnson
authors.forename: Elena
authors.initials: E
authors.lastname: Provenzano
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Pinder
authors.forename: Lilian
authors.initials: L
authors.lastname: Tee
authors.forename: Mai
authors.initials: M
authors.lastname: Gu
authors.forename: Elaine W
authors.initials: EW
authors.lastname: Kay
mesh_terms: D001331:Automation / Q000379:methods; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000737:chemistry*; D001943:Breast Neoplasms / Q000737:chemistry* / Q000378:metabolism / Q000473:pathology*; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods / Q000592:standards; D017404:In Situ Hybridization, Fluorescence / Q000379:methods / Q000592:standards; D009361:Neoplasm Invasiveness / Q000175:diagnosis; D009363:Neoplasm Proteins / Q000032:analysis* / Q000737:chemistry*; D016612:Paraffin Embedding; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis* / Q000737:chemistry*; D012107:Research Design; D012680:Sensitivity and Specificity; D013194:Staining and Labeling
chemical_list: D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human