development and preliminary evaluation of a multivariate index assay for ovarian cancer开发和初步评价的多元指数分析卵巢癌.pdfVIP

Development and Preliminary Evaluation of a Multivariate Index Assay for Ovarian Cancer . . Suraj D. Amonkar , Greg P. Bertenshaw , Tzong-Hao Chen, Katharine J. Bergstrom, Jinghua Zhao, Partha Seshaiah, Ping Yip, Brian C. Mansfield* Correlogic Systems, Inc., Rockville, Maryland, United States of America Abstract Background: Most women with a clinical presentation consistent with ovarian cancer have benign conditions. Therefore methods to distinguish women with ovarian cancer from those with benign conditions would be beneficial. We describe the development and preliminary evaluation of a serum-based multivariate assay for ovarian cancer. This hypothesis-driven study examined whether an informative pattern could be detected in stage I disease that persists through later stages. Methodology/Principal Findings: Sera, collected under uniform protocols from multiple institutions, representing 176 cases and 187 controls from women presenting for surgery were examined using high-throughput, multiplexed immunoassays. All stages and common subtypes of epithelial ovarian cancer, and the most common benign ovarian conditions were represented. A panel of 104 antigens, 44 autoimmune and 56 infectious disease markers were assayed and informative combinations identified. Using a training set of 91 stage I data sets, representing 61 individual samples, and an equivalent number of controls, an 11-analyte profile, composed of CA-125, CA 19-9, EGF-R, C-reactive protein, myoglobin, apolipoprotein A1, apolipoprotein CIII, MIP-1a, IL-6, IL-18 and tenascin C was identified and appears informative for all stages and common subtypes of ovarian cancer. Using a testing set of 245 samples, approximately twice the size