CIPH Ciphergen Biosystems (MM)

Ciphergen Reports on Disease Specific Inflammatory Diagnostics at AACR FREMONT, Calif., March 31 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. , in conjunction with the Johns Hopkins University School of Medicine, today presented data at the American Association for Cancer Research (AACR) 95th annual meeting in Orlando, Florida describing a novel approach to diagnostics based on the detection of combinations of protein fragments associated with the inflammatory response to disease. Ciphergen and its collaborators reported that different diseases generate unique host responses that can be distinguished by the quantitative detection of disease-specific protein fragments, potentially opening up a novel approach to multi-biomarker diagnostics. Ciphergen has applied for patents on this concept, which it calls the Host Response Protein Amplification Cascade (HR-PAC), and its use in diagnostic testing. Daniel Chan, Ph.D., Director of Clinical Chemistry at Johns Hopkins Medical Center, and senior author of the presentation, said, "We are very excited by these findings because they provide opportunities for diagnostic test development as well as insight into potential mechanism of disease. We are generating data from a variety of cancers that appear to support this hypothesis." Although it is well accepted that early detection of cancer can substantially increase treatment options and improve patient outcome, that endpoint has proven difficult to achieve, particularly for ovarian cancer. Traditional diagnostic approaches have started with the premise that tumor markers are proteins shed from the cancer cells themselves. However, this creates the dilemma that in their early stages, when tumors are small, only tiny quantities of potential biomarkers will be secreted and present in body fluids (e.g., serum) rendering them nearly impossible to detect. "This is a very interesting approach to diagnostics that has considerable potential. Discovery of markers for earlystage cancer remains problematic, and this represents a novel approach towards addressing that problem," stated Eleftherios P. Diamandis, M.D., Ph.D., Director of Clinical Biochemistry at Mount Sinai Hospital (Toronto). In today's presentation at AACR, data was presented showing the use of Ciphergen's SELDI ProteinChip(R) platform for biomarker discovery and SELDI-immunoassays to discover and assay for novel protein variants detected in serum protein profiles of 503 samples from women with ovarian cancer or benign pelvic masses, and from healthy controls. These biomarkers include truncated and modified forms of transthyretin and several fragments of a protein called ITIH4, and are believed to be produced by an inflammatory host response mechanism. These biomarkers were independently validated and showed, when combined in multi-marker sets, to have discriminatory power in separating patients with early stage ovarian cancer from healthy controls. Eric Fung, M.D., Ph.D., Director of Clinical Affairs for Ciphergen, and co-author, stated, "We propose that this inflammatory response cascade, which is present in even early stage tumors, may be manifested at a far greater level, or amplified, relative to any specific proteins emitted directly from the tumor itself. Ciphergen, in its discovery studies in various cancers, cardiovascular disease, infectious disease, and Alzheimer's disease, has discovered different combinations of protein amplification cascade fragments that may demonstrate the specificity of this approach and therefore a powerful and viable diagnostic strategy." About Ciphergen Ciphergen's Biosystems Division develops, manufactures and markets a family of ProteinChip(R) Systems and services for clinical, research, and process proteomics applications, as well as a broad range of bioseparations media for protein purification and large scale production. ProteinChip Systems enable protein discovery, characterization, identification and assay development to provide researchers with predictive, multi-marker assay capabilities and a better understanding of biological function at the protein level. Ciphergen's Diagnostics Division 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. 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 use of ProteinChip technology to discover useful protein biomarkers or protein fragments or to develop and commercialize clinical diagnostics that improve patient care, our ability to provide researchand development services that lead to improved toxicology assays and diagnostic assays, and our Diagnostics Division. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the ProteinChip technology's ability to validate and/or develop protein biomarkers or fragments as 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, including its Form 10-K dated March 15, 2004, for further information regarding these and the other risks of the Company's business. NOTE: Ciphergen, ProteinChip, BioSepra 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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