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HER2 testing in the UK: further update to recommendations

¹ Department of Cancer Studies and Molecular Medicine, University of Leicester, RKCSB, Leicester Royal Infirmary, Leicester, UK
² Endocrine Cancer Group, Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK
³ Department of Biochemistry, Royal Marsden Hospital, London, UK
⁴ Molecular Medical Sciences, University of Nottingham, Department of Histopathology, Nottingham University Hospital, Nottingham, UK
⁵ Pathology and Tumour Biology, Wellcome Trust, Leeds Institute for Molecular Medicine, St James University Hospital, Leeds, UK
⁶ Department of Pathology, School of Medicine, Cardiff University, Cardiff, UK
⁷ Department of Histopathology, University College Medical School, London, UK
⁸ Kings College London, Department of Academic Oncology, Guy’s Hospital, London, UK

Correspondence to:
R A Walker, Department of Cancer Studies and Molecular Medicine, University of Leicester, RKCSB, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK; raw14{at}le.ac.uk

These guidelines update the previous UK HER2 testing guidelines and have been formulated to give advice on methodology, interpretation and quality assurance to ensure that HER2 testing results are accurate, reliable and timely with the expansion of testing to all patients with breast cancer at the time of primary diagnosis. The recommendations for testing are the use of immunohistochemistry but with analysis of equivocal cases by in situ hybridisation to clarify their HER2 status or the use of frontline fluorescence in situ hybridisation (FISH) testing for those laboratories wishing to do so; the inclusion of a chromosome 17 probe is strongly recommended. Laboratories using chromogenic or silver in situ hybridisation should perform an initial validation against FISH. For immunohistochemistry and in situ hybridisation there must be participation in the appropriate National External Quality Assurance scheme.