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Clinical Chemistry 0: clinchem.2004.038687v1, 2004; 10.1373/clinchem.2004.038687
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Received on June 14, 2004
Accepted on August 25, 2004

Cancer Diagnostics

Mammaglobin as a Novel Breast Cancer Biomarker: Multigene Reverse Transcription-PCR Assay and Sandwich ELISA

Barbara K. Zehentner 1*, Amadou Deme 2, Papa Toure 2, Stephen E. Hawes 3, Lisa Brooks 1, Qinghua Feng 4, Dawn C. Hayes 1, David H. Persing 1, Cathy W. Critichlow 5, Raymond L. Houghton , Nancy B. Kiviat 4

1 Corixa Corporation, Seattle, WA
2 University of Dakar, Senegal, West Africa
3 Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, WA
4 Department of Pathology, School of Medicine, University of Washington, Seattle, WA
5 Department of Epidemiology, School of Public Health and Community Medicine

* To whom correspondence should be addressed. E-mail: zehentner{at}corixa.com.

Background: The aim of this study was to examine the potential usefulness of a mammaglobin multigene reverse transcription-PCR (RT-PCR) assay and a mammaglobin sandwich ELISA as diagnostic tools in breast cancer.

Methods: We studied peripheral blood samples from 147 untreated Senegalese women with biopsy-confirmed breast cancer and gathered patient information regarding demographic and clinical staging of disease. The samples were tested for mammaglobin and three breast cancer-associated gene transcripts by a multigene real-time RT-PCR assay and for serum mammaglobin protein by a sandwich ELISA assay.

Results: In 77% of the breast cancer blood samples, a positive signal was obtained in the multigene RT-PCR assay detecting mammaglobin and three complementary transcribed genes. Fifty samples from healthy female donors tested negative. Significant correlations were found among all pairs of the following: mammaglobin protein in serum, presence of mammaglobin mRNA-expressing cells in blood, stage of disease, and tumor size. Circulating mammaglobin protein was detected in 68% of the breast cancer sera, and was increased in 38% in comparison with a mixed control population. The RT-PCR assay and the ELISA for mammaglobin produced a combined sensitivity of 84% and specificity of 97%.

Conclusion: The ELISA and RT-PCR for mammaglobin and mammaglobin-producing cells could be valuable tools for diagnosis and prognosis of breast cancer.


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