CIPH Ciphergen Biosystems (MM)

FREMONT, Calif., March 5 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (NASDAQ:CIPH) presented data from a prospective clinical trial demonstrating that its ovarian triage test correctly identified 84 percent of the ovarian cancer cases, compared to only 33 percent identified using standard diagnosis methods without the test. The poster presentation was made at the Society of Gynecologic Oncologists 38th Annual Meeting on Women's Cancer in San Diego, Calif. on Sunday March 4, 2007. Ciphergen and its collaborators, the Oncologic Clinic Rigshospitalet, University of Copenhagen, The Danish Cancer Society and The Johns Hopkins Medical Institutions, analyzed pre-operative serum samples from 525 consecutive patients. "This prospective clinical trial validated that these markers improved both sensitivity and specificity in distinguishing ovarian cancer from benign pelvic masses," said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer for Ciphergen Biosystems. "Previous studies have demonstrated that early referral to gynecologic oncologist for diagnosis and appropriate surgical staging of cancer patients improves survival. In this study, given the historical referral rate to gynecologic oncologists of 33 percent of pelvic masses, this test could have more than doubled the ovarian cancer cases referred to the gynecologic oncologist." As the table below shows, the seven biomarker assay achieved a sensitivity of 84 percent, specificity of 80 percent, positive predictive value of 51 percent, and negative predictive value of 95 percent in the blinded test set. This was compared to a positive predictive value of 22 percent (the prevalence of cancer in this population), sensitivity of 33 percent, and specificity of 67 percent in the absence of the assay. Sensitivity Specificity Positive Negative Predictive Predictive Value Value Without Test 33% 67% 22% 78% CIPH Test Blinded set 84% 80% 51% 95% In addition to this completed prospective clinical trial, Ciphergen is currently enrolling patients in a clinical trial that seeks to demonstrate that the positive predictive value of the Ciphergen ovarian triage test is better than the current standard of care -- physical and radiological exam -- for distinguishing benign from malignant ovarian tumors. Ciphergen expects to submit the results of the trial to the U.S. Food and Drug Administration for clearance as an in vitro diagnostic. Information about enrollment can be found at http://clinicaltrials.gov/ under the identifier number NCT00436189. About Ciphergen's Ovarian Cancer Diagnostic Program In addition to developing a diagnostic designed to distinguish between benign and malignant pelvic masses, studies are underway to predict recurrence of ovarian cancer and to provide additional tools to aid physicians in triaging women considered at high risk of ovarian cancer. Ciphergen's comprehensive diagnostic development program is being conducted 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. About Ovarian Cancer Commonly known as the "silent killer," ovarian cancer leads to approximately 14,000 deaths each year in the United States. Approximately 23,000 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. About Ciphergen Ciphergen Biosystems, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Ciphergen, along with its prestigious scientific collaborators, has ongoing diagnostic programs in oncology/hematology, cardiology and women's health with an initial focus in ovarian cancer. Based in Fremont, California, more information about Ciphergen can be found on the Web at http://www.ciphergen.com/ . Safe Harbor Statement Note Regarding Forward-Looking Statements: This press release contains 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 projected performance of Ciphergen's ovarian cancer triage test. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the possibility that the clinical trial to evaluate the ovarian cancer triage test may have unexpected or negative results. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-Q filed November 20, 2006, for further information regarding these and other risks related to the Company's business. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: investors, Sue Carruthers of Ciphergen Biosystems, Inc., +1-510-505-2233; or media, Lori Murray of WeissComm Partners, +1-415-946-1070, for Ciphergen Biosystems, Inc. Web site: http://www.ciphergen.com/

Copyright