CIPHE Ciphergen Biosystems (MM)

Two Studies Published This Month Confirm Overlapping Biomarkers for Early Detection of Breast Cancer FREMONT, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (NASDAQ:CIPHE) announced today it is launching a formal breast cancer diagnostic development program based on a series of discoveries made using Ciphergen's Surface Enhanced Laser Desorption/Ionization (SELDI) technology and PatternTrack(TM) biomarker discovery process. The original study by Li (Clinical Chemistry 48(8) 1296-1304) published in 2002 detailed the discovery of three serum biomarkers that can improve detection of breast cancer. Two of the three markers have been identified and validated by two studies published this month. In the first study, Li et al (Clinical Chemistry 51 (2229-2235)) reported validation and identification of complement protein C3a as a biomarker for breast cancer. The sample cohort from three sites consisted of 46 age-matched healthy women, 32 with ductal carcinoma in situ (DCIS), 37 with various benign breast diseases and 61 with locally invasive breast cancer. In an independent study, Mathelin et al (Breast Cancer Research and Treatment, online article), reported confirmation of complement protein C3a as an up-regulated biomarker as well as confirmation of the down-regulation of breast cancer marker one (BC1) from Li's study. Identification of BC1 is ongoing. Ciphergen plans to expand their breast cancer diagnostic development program based on these promising results. Expanded studies are planned with Ciphergen's recent collaboration with University College of London (UCL) and UCL BioMedica Plc., which involves analysis of samples collected from 200,000 women for breast and ovarian cancer and is expected to complement our existing collaboration with Johns Hopkins School of Medicine. "Only 63% of breast cancers are localized at the time of diagnosis. Ideally, most women would prefer a simple blood test that would measure molecular markers for the presence of an early lesion. At Ciphergen, we are planning multi-site studies to validate several candidate biomarkers that could form the basis of a multi-marker assay to detect ductal carcinoma in situ (DCIS), since the majority of women diagnosed at this stage can be cured. Our goal is to develop a blood test that can be used in combination with sophisticated imaging techniques to improve the diagnosis of breast cancer," said Gail S. Page, President and Chief Operating Officer of Ciphergen Biosystems, Inc. Over the past few years, there have been notable studies utilizing SELDI-TOF-MS in diagnostic and prognostic areas of breast cancer research. While the development of biomarkers robust enough to meet the requirements for a diagnostic assay has driven extensive research over the past 20 years, recently the repeated discovery (overlap) of candidate biomarkers from independent studies are leading Ciphergen and its collaborators to embark upon an expanded development program aimed at understanding the specific biological pathways of early breast cancer and development of diagnostic and prognostic assays. 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 for disease diagnosis, prognosis, treatment response and for improved drug toxicology, efficacy and clinical trial stratification assays to speed pharmaceutical development. 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 http://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 diagnostic value of protein biomarkers, the expectation that protein multi-marker blood tests will address unmet clinical needs and improve patient care in the field of breast cancer, and the planned expansion of related collaborations and studies. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the possibility that biomarkers discovered by Ciphergen may fail to validate in expanded studies as providing an accurate diagnostic for breast cancer, the ProteinChip technology's ability to validate and/or develop protein biomarkers as novel diagnostic or toxicology assays, and the Company's ability to successfully commercialize such tests. Investors should consult Ciphergen's filings with the Securities and Exchange Commission for further information regarding these and other risks of the Company's business. NOTE: Ciphergen, ProteinChip and Biomarker Discovery Center are registered trademarks of Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: Sue Carruthers, Investor Relations of Ciphergen Biosystems, Inc., +1-510-505-2297 Web site: http://www.ciphergen.com/

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