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
- 1Department of Histopathology, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK
- 2Department of Biochemistry, The Royal Marsden Hospital, Fulham Road, London SW3 6JJ, UK
- 3University Department of Surgery, Glasgow Royal Infirmary, Level II, Queen Elizabeth Building, Alexandra Parade, Glasgow G31 2ER, UK
- 4University of Leicester, Department of Pathology, School of Medicine, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK
- 5Department of Biosciences, The University of Kent at Canterbury, Canterbury, Kent CT2 7NJ, UK
- 6Department of Pathology, Western Infirmary, Dumbarton Road, Glasgow G11 6NT, UK
- 7Verlindre Hospital, Whitchurch, Cardiff DF4 7XL, UK
- Dr Ellis
- Accepted 12 October 2000
Abstract
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.
