CIPH Ciphergen Biosystems (MM)

FREMONT, Calif., Dec. 19 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (NASDAQ:CIPH) today announced that it has engaged Emergo Group, Inc. to help gain regulatory clearance of Ciphergen's ovarian tumor triage test in various European countries. "Having obtained positive preclinical data in our ovarian cancer diagnostic program in studies performed with samples from European patients, we are seeking to rapidly pursue registration and commercialization of our ovarian tumor test in Europe," said Gail S. Page, President and CEO of Ciphergen. "The Emergo Group has an outstanding reputation for quality, value, and customer service that fits our efforts to move quickly to commercialize this test in at least one European country in 2007." Emergo Europe will act as the regulatory liaison between Ciphergen and the National Ministries of Health in Europe. Emergo Europe will register Ciphergen's in vitro diagnostics (IVDs) through the regulatory agencies in each country and provide consulting support on product packaging and labeling. Emergo is an ISO (International Standards Organization) registered medical device consulting firm with expertise in medical device regulatory affairs, CE marking and Good Manufacturing Practices (GMP) and ISO 13485 quality system implementation. "We are pleased to assist Ciphergen in their efforts to expeditiously register the ovarian tumor triage test in Europe as soon as possible," said Rene van de Zande, President and CEO of Emergo Group. About Ciphergen's Ovarian Cancer Diagnostic Program Ciphergen has an advanced diagnostic program in ovarian cancer and has developed a panel of biomarkers that provides risk stratification information for ovarian cancer based on a series of studies involving over 2,000 clinical samples from more than five sites. Ciphergen is undertaking a prospective clinical trial to support submission to the U.S. Food and Drug Administration for clearance as an in vitro diagnostic. Ciphergen has a strategic alliance with Quest Diagnostics focused on commercializing the ovarian tumor triage test. Quest also has the option to develop and commercialize two additional Ciphergen tests. In addition to developing a diagnostic test 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, 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 registration and commercialization of Ciphergen's test in Europe. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the possibility that despite the efforts of the company and its partners, the registration and commercialization of the tests may not occur as quickly as expected or at all. 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. NOTE: Ciphergen is a registered trademark of Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: Sue Carruthers, Investor Relations, Ciphergen Biosystems, Inc., +1-510-505-2233; or media, Daryl Messinger of WeissComm Partners, +1-415-999-2361, for Ciphergen Biosystems, Inc. Web site: http://www.ciphergen.com/

Copyright