Mortality from ovarian cancer (OvCa), the deadliest gynecological cancer in the United States has declined little for -50 years. When treated early, the 5-year survival rate is 93%, but only 19% are detected at stage I. Early-detection remains a critical, unmet medical need. Single diagnostic markers for OvCa have not been identified, although multivariate assays do offer promise. Common proteomic technologies lack ability to quantify multiple biomarkers simultaneously. Newer technologies lack sensitivity, precision and automation. Rules-Based Medicine (RBM) resolved these limitations by developing bead-based, multiplexed immunoassays for identifying disease-specific Multi-Analyte Profiles (MAPs). Combining MAPs and pattern recognition algorithms, Correlogic and RBM are developing an informational test to be used in conjunction with existing tests and observations, to screen high-risk women facing surgery for suspicion of OvCa. A preliminary multi-variate test with 95% sensitivity overall (88% stage I; 92% stage II) with >70% specificity has been developed. Higher specificity would open the test to a wider population. In Phase I, we propose improving the performance of the existing MAP-based assay by integrating 7 additional analytes associated with OvCa. If successful, this program has a valuable commercial application for the 11 million US women considered high-risk for developing OvCa.
