Cln101 and Ovr110 as novel serum markers for detection of ovarian cancer

Abstract

5033 Background: We have identified, through genomic data mining, mRNA expression profiling, and secretory domain characterization, two novel serum cancer markers, Cln101 and Ovr110. We have measured the levels of Cln101 and Ovr110 in over 2500 serum samples, and compared their sensitivity and specificity in ovarian cancer to CA125. Methods: A sensitive dual monoclonal antibody sandwich ELISA for Cln101 and Ovr110 were developed. The assays were used to test serum sample set that included 555 normal controls, 1023 cancer samples, and 997 samples from various benign diseases. CA125 levels were measured on the same samples using Lumipulse bioanalyzer (FujiRebio, Tokyo, Japan). The sensitivity and specificity of each marker, and combinations of the markers, were analyzed by Receiver Operating Characteristic (ROC) curves in univariate and multivariate analyses. Results: Levels of Cln101 and Ovr110 were elevated in ovarian cancer patients when compared to healthy controls or women with benign ovarian diseases. The two markers had either comparable, or better sensitivity and specificity in detecting ovarian cancer than the traditional tumor marker, CA125. The table below shows Area Under the Curve (AUC) of all markers tested in univariate and multivariate analysis. Conclusions: These findings suggest that Cln101 and Ovr110 are promising serum markers for ovarian cancer that could improve the sensitivity of traditional ovarian cancer serum markers. Additional studies are planned to confirm and expand the current findings. *AUC derived from ROC analyses comparing cancer vs. normal + benigns Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration diaDexus, Inc. diaDexus, Inc. diaDexus, Inc. diaDexus Inc. diaDexus, Inc. diaDexus, Inc.