FREMONT, Calif., June 5 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. announced today results of a multi-center study evaluating the performance of a set of seven biomarkers for the detection of ovarian cancer. 607 patient samples taken from five international medical centers were evaluated for each of the seven markers. 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 MD 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 multi-institutional 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.
About Ciphergen
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(R) laboratories for biomarker discovery for new diagnostic tests as well as pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays. Ciphergen develops, manufactures and markets a family of ProteinChip(R) Systems and services for clinical, research and process proteomics applications. ProteinChip Systems enable protein discovery, validation, identification and assay development to provide researchers with predictive, multi-marker assay capabilities and a better understanding of biological function at the protein level. Additional information about Ciphergen can be found at www.ciphergen.com.
Safe Harbor Statement
Note Regarding Forward-Looking Statements: For purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”), Ciphergen disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such forward-looking statements include statements regarding the predictive value and usefulness of the reported multi-marker panel in helping triage women being evaluated with a persistent pelvic mass or pelvic pain, the impact on patient outcome of patient referrals to a specialist gynecologist , the potential outcome of studies designed to predict recurrence of ovarian cancer and/or to act as a tool to aid a physician in triaging women considered at high risk of ovarian cancer, and the ability of Ciphergen to create diagnostic tests to aid physicians in predicting recurrence of ovarian cancer and/or triaging women considered at high risk of ovarian cancer. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the fact that the performance of this or any other multi-marker panel discovered by Ciphergen may not validate in subsequent studies or be developed into an assay that is useful to physicians and patients. Investors should consult Ciphergen’s filings with the Securities and Exchange Commission, including its Form 10-K dated March 17, 2006, for further information regarding these and other risks of the Company’s business.
NOTE: Ciphergen, ProteinChip, Biomarker Discovery Center are registered trademarks of Ciphergen Biosystems, Inc.
Ciphergen Biosystems, Inc.
CONTACT: Sue Carruthers, Investor Relations of Ciphergen Biosystems, Inc.,+1-510-505-2297
Web site: http://www.ciphergen.com//
