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Clinical Chemistry 50: 2069-2076, 2004. First published September 16, 2004; 10.1373/clinchem.2004.038687
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(Clinical Chemistry. 2004;50:2069-2076.)
© 2004 American Association for Clinical Chemistry, Inc.

Cancer Diagnostics

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

Barbara K. Zehentner1,1, David H. Persing1,a, Amadou Deme2, Papa Toure2, Stephen E. Hawes3, Lisa Brooks1, Qinghua Feng4, Dawn C. Hayes1, Cathy W. Critichlow3, Raymond L. Houghton and Nancy B. Kiviat4

1 Corixa Corporation, Seattle, WA.
2 University of Dakar, Senegal, West Africa.
3 Department of Epidemiology, School of Public Health and Community Medicine, and4 Department of Pathology, School of Medicine, University of Washington, Seattle, WA.

aAddress correspondence to this author at: Corixa Corporation, 1900 9th Ave., Suite 1100, Seattle, WA 98101. Fax 206-366-3759; e-mail David.Persing{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 between 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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