Related Experiment Video
Updated: Apr 18, 2026
Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
Published on: May 9, 2025
Incorporating microarray assessment of HER2 status in clinical practice supports individualised therapy in
Kathleen A Grant1, Fredrieka M Pienaar2, Karen Brundyn3
1Division of Anatomical Pathology, Department of Pathology, Faculty of Medicine and Health Sciences, University of Stellenbosch, Tygerberg, South Africa; Department of Biomedical Sciences, Faculty of Health and Wellness, Cape Peninsula University of Technology, Bellville, South Africa.
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.
