Clinical Studies and New Developments with Hybri-BREScan (CA-549), A Monoclonal Assay for Breast Cancer-Associated Antigen
Hybri-BREScan antigen (formerly CA-549) is a circulating tumor associated antigen that is often elevated in the sera of breast cancer patients. Preliminary studies of this antigen have shown it to have utility in the monitoring of breast cancer disease status. Biochemical analyses have shown that this antigen is a member of the heterogeneous family of high molecular weight, mucin-like glycoproteins found in human milk fat globule membranes.
Clinical trials at four sites using Hybri-BREScan immuno-radiometric assay to measure antigen in serum showed good assay performance: interassay precision and intra-assay precision were 6.2% and 5.2% cv, respectively, with a minimum detectable concentration of 0.12 U/ml. The normal range was determined to be 0–12 U/ml.
KeywordsBreast Cancer Breast Cancer Patient Radiometric Assay Clinical Trial Site Interassay Precision
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