FREMONT, Calif., March 23 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. announced today results of a prospective clinical study evaluating the performance of a multi-marker panel that is designed to help triage women being evaluated for a persistent pelvic mass or with pelvic pain. This study was performed in conjunction with Professor Claus Hogdall at Rigshospitalet, University of Copenhagen. The study evaluated 202 consecutive patients with suspicion of a primary ovarian tumor, endometriosis or with pelvic pain. Data from 126 women were used for training, and data from the remaining 76 women were used for blinded testing. The marker panel, which consists of seven markers previously identified in studies with The Johns Hopkins School of Medicine, the University of Texas M. D. Anderson Cancer Center, and the University of Kentucky, provided substantial benefit in increased positive predictive value (the percentage of time a positive test result is actually positive). The marker panel, when combined with CA125, had a positive predictive value in the blinded testing set of 80%, in contrast to 59% for CA125 alone.
“These results validate our previous findings in a rigorous, prospective clinical study,” said Gail S. Page, President and CEO of Ciphergen. “Appropriate triage of women with suspicion of ovarian cancer is necessary so that women who do have ovarian cancer may be referred to the specialist gynecologic oncologist. It has been demonstrated that this referral has an important impact in patient outcome.”
According to The American College of Obstetricians and Gynecologists (ACOG), approximately 5-10% of women in the U.S. will undergo a surgical procedure for a suspected ovarian neoplasm during their lifetime. A significant proportion (approximately 20%) of women with pelvic masses have malignant disease, and the proportion becomes even higher among post-menopausal women. It has been demonstrated in several studies, including most recently in the February 1, 2006 issue of the Journal of the National Cancer Institute, that early referral to gynecologic oncologists for laparotomy and appropriate surgical staging of cancer patients improves survival.
The particular study presented today at the SGO Annual Meeting is part of a comprehensive ovarian cancer program being conducted by Ciphergen in conjunction with several 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 and BioSepra are registered trademarks of Ciphergen Biosystems, Inc.
Ciphergen Biosystems, Inc.
CONTACT: investors, Sue Carruthers of Ciphergen Biosystems, Inc.,+1-510-505-2297
Web site: http://www.ciphergen.com//
