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

Research output: Contribution to journalArticlepeer-review

63 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
Externally publishedYes


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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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