Protein Biomarkers Useful For Diagnosis Of Early-Stage Ovarian Cancer

Detection of early-stage ovarian cancer

Ciphergen Biosystems Inc. presented data on the discovery of several protein biomarkers that may be potential diagnostic markers in detection of early-stage ovarian cancer.

These findings support one of three diagnostic programs that Ciphergen currently has under development for ovarian cancer. These findings were presented at the American Association for Cancer Research Annual Meeting in Los Angeles, Calif.

"Development of a reliable test for the diagnosis of early-stage ovarian cancer should contribute to improving overall survival in patients," said Robert C. Bast, Jr., M.D., Vice President of Translational Medicine, and Professor of Experimental Therapeutics at, M.D. Anderson Cancer Center, University of Texas, co-author of the presentation and member of the Ciphergen Scientific Advisory Board.

Ciphergen and its collaborators discovered four proteins in urine that separate women with early cancer from healthy individuals with a sensitivity of 56% and a specificity of 95%. These results suggest the possibility that these proteins in combination with other biomarkers, could aid in the diagnosis of early-stage ovarian cancer. To elucidate these findings Ciphergen employed protein expression profiling methods to analyze urine samples from 400 women, including 288 women with epithelial ovarian cancer, 52 with early stage disease and 176 with late stage disease, 74 women with benign ovarian disease and 98 normal, healthy controls.

"These promising results provide the foundation for additional studies across a larger population of women," said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer for Ciphergen Biosystems. "By demonstrating that these findings are reproducible, Ciphergen hopes to advance these markers beyond the clinical validation process and into clinical trials."

Ciphergen has multiple ovarian cancer diagnostic tests in development, including an ovarian cancer triage test designed to distinguish between benign and malignant pelvic masses, one to predict recurrence of ovarian cancer and a test to aid physicians in identifying women considered at high risk for ovarian cancer. These findings support Ciphergen's diagnostic program with high-risk, early-stage disease.

Ciphergen is currently enrolling patients in a prospective clinical trial for its ovarian cancer triage test to evaluate whether the positive predictive value of the test is better than the current standard of care - physical and radiological exam - for distinguishing benign from malignant ovarian tumors. Enrollment information is available at clinicaltrials.gov, identifier NCT00436189.