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Recommendations for HER2 testing in the UK

I O Ellis¹, M Dowsett², J Bartlett³, R Walker⁴, T Cooke³, W Gullick⁵, B Gusterson⁶, E Mallon⁶, P Barrett Lee⁷

¹ Department of Histopathology, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK
² Department of Biochemistry, The Royal Marsden Hospital, Fulham Road, London SW3 6JJ, UK
³ University Department of Surgery, Glasgow Royal Infirmary, Level II, Queen Elizabeth Building, Alexandra Parade, Glasgow G31 2ER, UK
⁴ University of Leicester, Department of Pathology, School of Medicine, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK
⁵ Department of Biosciences, The University of Kent at Canterbury, Canterbury, Kent CT2 7NJ, UK
⁶ Department of Pathology, Western Infirmary, Dumbarton Road, Glasgow G11 6NT, UK
⁷ Verlindre Hospital, Whitchurch, Cardiff DF4 7XL, UK

Correspondence to:
Dr Ellis

Determining the HER2 status of breast carcinomas is a prerequisite for the use of the monoclonal antibody trastuzumab (Herceptin®), which has recently been licensed for the treatment of metastatic disease. This necessitates a test based on archival material. The preferred analyses are immunohistochemistry with fluorescent in situ hybridisation (FISH) as a follow up test for ambiguous results. Guidelines have been developed for standardised, well controlled procedures for the provision of reliable results. A group of three reference laboratories has been established to provide advice, quality assurance, and materials, where needed.

Key Words: HER2 • breast cancer • Herceptin^®

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