Protein Biomarkers Help Diagnose Early-Stage Ovarian Cancer

Ciphergen (Freemont, CA, USA) researchers and 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.

Development of a reliable test for the diagnosis of early-stage ovarian cancer should contribute to improving overall survival in patients, said Prof. Robert C. Bast, Jr., vice president of translational medicine, and professor of experimental therapeutics at M.D. Anderson Cancer Center, University of Texas (Houston, TX, USA), hwo is a co-author of the presentation and member of the Ciphergen scientific advisory board.

These promising results provide the foundation for additional studies across a larger population of women, said Eric T. Fung, M.D., Ph.D., and CSO 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; a test to predict recurrence of ovarian cancer, and another 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.

Commonly known as the silent killer, ovarian cancer leads to approximately 15,000 deaths each year in the United States, according to the American Cancer Society. Approximately 20,000 new cases are diagnosed each year, with the majority in patients diagnosed with late stage disease, where the cancer has spread beyond the ovary. The prognosis is poor in these patients, leading to the high mortality from this disease. A diagnostic test is needed that can provide adequate predictive value to stratify patients with a pelvic mass into high risk of invasive ovarian cancer versus those with low risk, as well as a screening test for the diagnosis of early-stage ovarian cancer, which is essential for improving overall survival in patients. Ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy if detected in stage 1.


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M.D. Anderson Cancer Center