Please use this identifier to cite or link to this item: http://hdl.handle.net/11189/5791
Title: Incorporating microarray assessment of HER2 status in clinical practice supports individualised therapy in early-stage breast cancer
Authors: Kathleen A. Grant, KA 
Fredrieka M. Pienaar, FM 
Brundyn, Karen 
Swart, Gillaume 
Gericke, George. S 
Myburgh, Ettienne. J 
Wright, Colleen. A 
Apffelstaedt, Justus.P 
Kotze, Maritha. J 
Keywords: Analytical validation;Breast cancer;HER2 status;MammaPrint prescreen algorithm;TargetPrint microarray;Quality assurance
Issue Date: 2015
Publisher: Elsevier
Abstract: Accurate determination of human epidermal growth factor receptor-2 (HER2) status is essential for optimal selection of breast cancer patients for gene targeted therapy. The analytical performance of microarray analysis using TargetPrint for assessment of HER2 status was evaluated in 138 breast tumours, including 41 fresh and 97 formalin-fixed paraffin embedded (FFPE) specimens. Reflex testing using immunohistochemistry/in situ hybridization (IHC/ISH) in four discordant cases confirmed the TargetPrint results, achieving 100% agreement regardless of whether fresh tissue or FFPE specimens were used. One equivocal IHC/ISH case was classified as HER2-positive based on the microarray result. The proven clinical utility in resolving equivocal and borderline cases justifies modification of the testing algorithm under these circumstances, to obtain a definitive positive or negative test result with the use of microarrays. Determination of HER2 status across three assay platforms facilitated improved quality assurance and led to a higher level of confidence on which to base treatment decisions.
URI: https://doi.org/10.1016/j.breast.2014.12.006
http://hdl.handle.net/11189/5791
ISSN: 1532-3080
Appears in Collections:HWSci - Journal Articles (DHET subsidised)

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