Comparison of central HER2 testing with quantitative total HER2 expression and HER2 homodimer measurements using a novel proximity-based assay

Weidong Huang, Monica Reinholz, Jodi Weidler, Yolanda Lie, Agnes Paquet, Jeannette Whitcomb, Wilma Lingle, Robert B. Jenkins, Beiyun Chen, Jeffrey S. Larson, Yuping Tan, Thomas Sherwood, Michael Bates, Edith A. Perez

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

The accuracy and reliability of immunohistochemical analysis and in situ hybridization for the assessment of HER2 status remains a subject of debate. We developed a novel assay (HERmark Breast Cancer Assay, Monogram Biosciences, South San Francisco, CA) that provides precise quantification of total HER2 protein expression (H2T) and HER2 homodimers (H2D) in formalin-fixed, paraffin-embedded tissue specimens. H2T and H2D results of 237 breast cancers were compared with those of immunohistochemical studies and fluorescence in situ hybridization (FISH) centrally performed at the Mayo Clinic, Rochester, MN. H2T described a continuum across a wide dynamic range (∼2.5 log). Excluding the equivocal cases, HERmark showed 98% concordance with immunohistochemical studies for positive and negative assay values. For the 94 immunohistochemically equivocal cases, 67% and 39% concordance values were observed between HERmark and FISH for positive and negative assay values, respectively. Polysomy 17 in the absence of HER2 gene amplification did not result in HER2 overexpression as evaluated quantitatively using the HERmark assay.

Original languageEnglish (US)
Pages (from-to)303-311
Number of pages9
JournalAmerican journal of clinical pathology
Volume134
Issue number2
DOIs
StatePublished - Aug 1 2010

Keywords

  • Breast cancer
  • Central HER2 testing
  • Concordance
  • HER2 homodimers
  • Polysomy 17
  • Quantitative total HER2 expression

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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    Huang, W., Reinholz, M., Weidler, J., Lie, Y., Paquet, A., Whitcomb, J., Lingle, W., Jenkins, R. B., Chen, B., Larson, J. S., Tan, Y., Sherwood, T., Bates, M., & Perez, E. A. (2010). Comparison of central HER2 testing with quantitative total HER2 expression and HER2 homodimer measurements using a novel proximity-based assay. American journal of clinical pathology, 134(2), 303-311. https://doi.org/10.1309/AJCP3BZY4YAFNTRG