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.
Pinder, Sarah E
Kay, Elaine W
AffiliationDepartment of Pathology, R.C.S.I. Education & Research Centre, Beaumont Hospital, Dublin 9, Ireland. firstname.lastname@example.org
Guidelines as Topic
In Situ Hybridization, Fluorescence
Sensitivity and Specificity
Staining and Labeling
Tumor Markers, Biological
MetadataShow full item record
CitationAn 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. 2010, 18 (6):489-93 Appl. Immunohistochem. Mol. Morphol.
JournalApplied immunohistochemistry & molecular morphology : AIMM / official publication of the Society for Applied Immunohistochemistry
AbstractImmunohistochemistry (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.
- Validation of a fully automated HER2 staining kit in breast cancer.
- Authors: Moelans CB, Kibbelaar RE, van den Heuvel MC, Castigliego D, de Weger RA, van Diest PJ
- Issue date: 2010
- Gene protein detection platform--a comparison of a new human epidermal growth factor receptor 2 assay with conventional immunohistochemistry and fluorescence in situ hybridization platforms.
- Authors: Stålhammar G, Farrajota P, Olsson A, Silva C, Hartman J, Elmberger G
- Issue date: 2015 Aug
- HER2 amplification status in breast cancer: a comparison between immunohistochemical staining and fluorescence in situ hybridisation using manual and automated quantitative image analysis scoring techniques.
- Authors: Ellis CM, Dyson MJ, Stephenson TJ, Maltby EL
- Issue date: 2005 Jul
- Analysis of HER2 status in breast carcinoma by fully automated HER2 fluorescence in situ hybridization (FISH): comparison of two immunohistochemical tests and manual FISH.
- Authors: Yoon N, Do IG, Cho EY
- Issue date: 2014 Sep
- Comparison of automated and manual determination of HER2 status in breast cancer for diagnostic use: a comparative methodological study using the Ventana BenchMark automated staining system and manual tests.
- Authors: Bánkfalvi A, Boecker W, Reiner A
- Issue date: 2004 Oct