REVIEW

Best Practice No 176

Updated recommendations for HER2 testing in the UK

I O Ellis¹, J Bartlett², M Dowsett³, S Humphreys⁴, B Jasani⁵, K Miller⁶, S E Pinder¹, A Rhodes⁶, R Walker⁷

¹ Department of Histopathology, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK (National Coordinating Group for Breast Pathology and National HER2 Reference Laboratory)
² University Department of Surgery, Glasgow Royal Infirmary, Glasgow G4 0SF, UK (National HER2 Reference Laboratory Service)
³ Department of Biochemistry, Royal Marsden Hospital, London SW3 6JJ, UK (National HER2 Reference Laboratory Service)
⁴ Department of Cellular Pathology, Preston Hall Hospital, Maidstone, Kent ME20 7NJ, UK (National Coordinating Group for Breast Pathology)
⁵ Department of Pathology, University of Wales College of Medicine, Cardiff CF14 4XN, UK (United Kingdom National External Quality Assessment Scheme for Immunocytochemistry)
⁶ Department of Histopathology, University College London Medical School, London WCIE 6JJ, UK (United Kingdom National External Quality Assessment Scheme for Immunocytochemistry)
⁷ Department of Pathology, University of Leicester, Leicester, UK (National Coordinating Group for Breast Pathology)

Correspondence to:
Correspondence to:
Dr I O Ellis
Department of Histopathology, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK; ian.ellis{at}nottingham.ac.uk

This paper serves to update previously published guidance on rationale and methodology for HER2 laboratory testing following the recommendation for the use of HER2 targeted treatment in the management of advanced breast cancer in the UK. Emphasis is placed on the standardisation of methodology and assessment and strategies to achieve high quality performance. A two phase testing algorithm based on first line immunocytochemistry evaluation and second line fluorescence in situ hybridisation assessment of borderline cases is recommended. To ensure maintenance of expertise, an annual caseload volume of at least 250 cases is recommended for laboratories providing a testing service.

Keywords: breast cancer; HER2; UK; guidelines; laboratory testing

Abbreviations: FISH, fluorescence in situ hybridisation; IHC, immunohistochemistry; NICE, National Institute for Clinical Excellence; UK NEQAS-ICC, United Kingdom National External Quality Assessment Scheme for Immunocytochemistry

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