Genetic heterogeneity in HER2 testing in breast cancer panel summary and guidelines

Gail H. Vance, Todd S. Barry, Kenneth J. Bloom, Patrick L. Fitzgibbons, David G. Hicks, Robert B. Jenkins, Diane L. Persons, Raymond R. Tubbs, M. Elizabeth H. Hammond

Research output: Contribution to journalArticlepeer-review

190 Scopus citations


• Context.-Intratumoral heterogeneity of HER2 gene amplification has been well documented and represents subclonal diversity within the tumor. The reported incidence of intratumor HER2 amplification genetic heterogeneity ranges in the literature from approximately 5% to 30%. The presence of HER2 genetic heterogeneity may increase subjectivity in HER2 interpretation by the pathologist. Objectives.-To define HER2 genetic heterogeneity and to provide practice guidelines for examining and reporting breast tumors with genetic heterogeneity for improvement of HER2 testing in breast cancer. Design.-We convened an expert panel to discuss HER2 gene amplification testing by fluorescence in situ hybridization. Components addressed included a definition of HER2 amplification heterogeneity, practice guidelines for examination of the tissue, and reporting criteria for this analysis. Results.-Genetic heterogeneity for amplification of HER2 gene status in invasive breast cancer is defined and guidelines established for assessing and reporting HER2 results in these cases. These guidelines are additive to and expand those published in 2007 by the American Society of Clinical Oncology and the College of American Pathologists. Conclusion.-Standardized methods for analysis will improve the accuracy and consistency of interpretation of HER2 gene amplification status in breast cancer.

Original languageEnglish (US)
Pages (from-to)611-612
Number of pages2
JournalArchives of Pathology and Laboratory Medicine
Issue number4
StatePublished - Apr 2009

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology


Dive into the research topics of 'Genetic heterogeneity in HER2 testing in breast cancer panel summary and guidelines'. Together they form a unique fingerprint.

Cite this