Recommendations for HER2 testing in the UK.
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.
Ellis
I O
IO
Department of Histopathology, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. ian.ellis@nottingham.ac.uk
Dowsett
M
M
Bartlett
J
J
Walker
R
R
Cooke
T
T
Gullick
W
W
Gusterson
B
B
Mallon
E
E
Lee
P B
PB
D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000737:chemistry*; D005260:Female; D006801:Humans; D007120:Immunochemistry; D017404:In Situ Hybridization, Fluorescence; D009363:Neoplasm Proteins / Q000032:analysis*; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*
D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins; D018719:Erb-b2 Receptor Tyrosine Kinases