Clinical utility of serum HER-2/neu testing on the bayer immuno 1® automated system in breast cancer

G. B. Cook, I. E. Neaman, J. L. Goldblatt, D. R. Cambetas, M. Hussain, D. Lüftner*, K. K. Yeung, D. W. Chan, M. K. Schwartz, W. J. Allard

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

64 Scopus citations


The clinical utility of automated serum HER-2/neu measurements in breast cancer run on the Bayer random analyzer Immuno 1® was analyzed in several steps: [a] The reference interval was determined for 242 normal healthy preand postmenopausal females. [b] The clinical specificity of serum HER-2/neu to separate healthy controls from 210 patients with non-malignant breast - and non-breast diseases was calculated. [c] The clinical sensitivity of cross-sectional serum HER-2/neu values for 204 patients (pts) with stage I-IV breast cancer was established. [d] Specimens from 103 stage IV breast cancer pts were tested for their parallel between serial serum HER-2/neu results and disease course. Results: [a] The value of 13.03 ng/ml exceeded 95% of the results from the healthy female population. Based on the mean +2 standard deviations value of 14.7 ng/dl, the upper limit of normal was established at 15 ng/ml. [b] The specificity for benign breast diseases and other benign non-breast diseases was 98.0% and 94.6%, respectively. [c] The correlation of increased serum HER-2/neu levels and stage of breast cancer revealed the best sensitivity of 40% for stage IV disease. [4] Thirty-eight (36.9%) of 103 stage IV patients had initial HER-2/neu values > 15 ng/ml, 33 of whom showed longitudinal HER-2/neu concentrations which paralleled the clinical course of the disease giving a sensitivity of 86.8%.

Original languageEnglish (US)
Pages (from-to)1465-1470
Number of pages6
JournalAnticancer Research
Issue number2 B
StatePublished - Jun 11 2001


  • Breast cancer
  • Immuno 1® automated system
  • Serum HER-2/neu

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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