Mortality from ovarian cancer (OvCa), the deadliest gynecological cancer in the United States has declinedlittle 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 beenidentified, although multivariate assays do offer promise. Common proteomic technologies lack ability toquantify multiple biomarkers simultaneously. Newer technologies lack sensitivity, precision and automation.Rules-Based Medicine (RBM) resolved these limitations by developing bead-based, multiplexedimmunoassays for identifying disease-specific Multi-Analyte Profiles (MAPs). Combining MAPs and patternrecognition algorithms, Correlogic and RBM are developing an informational test to be used in conjunctionwith existing tests and observations, to screen high-risk women facing surgery for suspicion of OvCa. Apreliminary multi-variate test with 95% sensitivity overall (88% stage I; 92% stage II) with >70% specificityhas been developed. Higher specificity would open the test to a wider population. In Phase I, we proposeimproving the performance of the existing MAP-based assay by integrating 7 additional analytes associatedwith OvCa. If successful, this program has a valuable commercial application for the 11 million US womenconsidered high-risk for developing OvCa.
