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Related Experiment Videos

Breast cancer marker Ca549. A multicenter study

D W Chan1, R A Beveridge, A Bhargava

  • 1Department of Pathology, Johns Hopkins University and Hospital, Baltimore, Maryland 21287-7065.

American Journal of Clinical Pathology
|April 1, 1994
PubMed
Summary
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The CA549 marker shows promise for breast cancer detection, particularly in advanced stages. Assay validation confirms its reliability for clinical use in diagnosing breast cancer.

Area of Science:

  • Oncology
  • Biochemistry
  • Clinical Diagnostics

Background:

  • CA549 is a potential biomarker for breast cancer.
  • Accurate and reliable assays are crucial for biomarker validation.

Purpose of the Study:

  • To evaluate the performance of the BRESMARQ assay for CA549.
  • To establish reference intervals and assess CA549 levels in various conditions.

Main Methods:

  • A multicenter study involving 1721 patients and 746 healthy individuals.
  • Immunoradiometric assay (BRESMARQ) used for CA549 quantification.
  • Assay validation included precision, sensitivity, linearity, recovery, and interference studies.

Main Results:

  • The BRESMARQ assay demonstrated acceptable performance across multiple validation parameters.

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  • Reference intervals were established: 0-12.5 kU/L (women) and 0-11.9 kU/L (men).
  • Elevated CA549 levels were observed in various benign and malignant conditions, with higher prevalence in advanced breast cancer (Stage IV: 74%).

    • Conclusions:

    • CA549, measured by the BRESMARQ assay, is a reliable marker for breast cancer.
    • The marker shows significant utility in identifying Stage IV breast cancer, as indicated by receiver-operating characteristic analysis.