HER2+ breast cancer: Review of biologic relevance and optimal use of diagnostic tools

David G. Hicks, Swati Kulkarni

Research output: Contribution to journalReview articlepeer-review

119 Scopus citations


Clinical laboratory testing for human epidermal growth factor receptor 2 (HER2) status in newly diagnosed breast cancer is critically important for therapeutic decision making. Unlike most pathologic testing, which serves as an adjunct to establishing a diagnosis, the results of HER2 testing stand alone in determining which patients are likely to respond to trastuzumab, a monoclonal antibody against HER2. Given the significant clinical impact of the testing results on subsequent patient management, the accuracy, precision, and reproducibility of HER2 testing are critical. At present, several preanalytic factors, including the time from tissue removal to tissue fixation, are underappreciated as important variables that have the potential to negatively impact the consistency and reliability of HER2 testing. Rigorous quality control and standardization of the testing process, from the handling of tissue samples to interpretation and reporting of results, are essential for achieving accurate and reproducible assay results.

Original languageEnglish (US)
Pages (from-to)263-273
Number of pages11
JournalAmerican journal of clinical pathology
Issue number2
StatePublished - Feb 2008


  • Breast cancer
  • Concordance
  • Fluorescence in situ hybridization
  • Guidelines
  • HER2
  • Immunohistochemistry
  • Proficiency testing
  • Trastuzumab
  • Validation

ASJC Scopus subject areas

  • Pathology and Forensic Medicine


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