Multicenter Validation Ovarian Cancer Biomarker Study

Ciphergen Biosystems, Inc. (CIPH) announced results of a multicenter study evaluating the performance of a set of seven biomarkers for the detection of ovarian cancer. Six hundred seven (607) patient samples taken from five international medical centers were evaluated for each of the seven markers. Two hundred thirty four (234) women had benign gynecologic disease and 373 patients had invasive epithelial ovarian cancer, including 101 with early stage cancer.

All seven biomarkers individually demonstrated statistically significant power to differentiate ovarian cancer patients from women with benign disease, and most biomarkers had p<.00001. As in previous studies, an index derived from the seven markers demonstrated improved specificity for discriminating ovarian cancer from benign pelvic masses, as well as for the detection of early stage cancer.This is the first time that biomarkers discovered through current clinical proteomics efforts have been subjected to a large-scale multi-institutional independent validation study.

The Johns Hopkins Medical Institutions; University of Texas M.D. Anderson Cancer Center; University Hospitals, Leuven, Belgium; Rigshositalet, University of Copenhagen Hospital, Copenhagen, Denmark; University of Kentucky; and Groningen University Medical Center, Groningen, The Netherlands participated in the study. The paper was presented by Dr. Zhen Zhang, associate professor, Department of Pathology, The Johns Hopkins University School of Medicine.

"We are very pleased with the results of this study. Demonstrating the multi-center validity of our markers is a key milestone in the development of a test that can aid in distinguishing women with ovarian cancer from women with benign ovarian tumors," said Gail S. Page, president and CEO. "We have now shown the utility of these markers in large multiinstitutional retrospective studies as well as in prospective studies."

The particular study presented at the ASCO Annual Meeting is part of a comprehensive ovarian cancer program being conducted by Ciphergen in conjunction with leading collaborators at The Johns Hopkins School of Medicine, the University of Texas M.D. Anderson Cancer Center, University College London, and the University of Kentucky. In addition to the ongoing work aimed at developing assays that are designed to distinguish between benign and malignant pelvic mass, Ciphergen has studies underway to target the prediction of recurrence of ovarian cancer as well as to provide additional tools to aid the physician in triaging women considered at high risk of ovarian cancer.

Ciphergen is dedicated to the discovery of protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests that improve patient care; and to providing collaborative R&D services through its Biomarker Discovery Center laboratories for biomarker discovery for new diagnostic tests as well as pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays.