Testing for HER2 in breast cancer

Histopathology. 2004 Sep;45(3):207-17. doi: 10.1111/j.1365-2559.2004.01903.x.


HER2 is a paradigm of a molecular target whose appropriate assessment is pivotal in the targeting of novel therapies for breast cancer, notably including Herceptin/Trastuzumab. Determining the correct levels requires immunohistochemical and molecular biological skills that are reproducible and measurable, coupled with a knowledge of the appropriate morphological and pathobiological context. Attaining these goals is not easy and laboratories testing for HER2 should maintain a high level of throughput of tests and engage in a recognized external quality assurance scheme. Fluorescence in-situ hybridization testing remains a particular challenge and there is a range of testing strategies. This testing forms the model for the identification of other novel molecular targets. In the future rapid throughput techniques such as real-time quantitative polymerase chain reaction (rqPCR), tissue microarrays or both should bring significant economies of cost and scale.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Breast Neoplasms / diagnosis*
  • Breast Neoplasms / genetics
  • Breast Neoplasms / metabolism
  • Female
  • Genetic Testing
  • Humans
  • Immunohistochemistry / methods
  • In Situ Hybridization, Fluorescence / methods
  • Receptor, ErbB-2 / analysis
  • Receptor, ErbB-2 / genetics*
  • Reproducibility of Results
  • Sensitivity and Specificity


  • Receptor, ErbB-2