CIPH Ciphergen Biosystems (MM)

National Cancer Institute's Early Detection Research Network Reports Platform and Clinical Reproducibility of Ciphergen's SELDI ProteinChip(R) System for Detection of Prostate Cancer Study Results Reported in Clinical Chemistry FREMONT, Calif., Jan. 18 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (NASDAQ:CIPH) announced today that the National Cancer Institute's Early Detection Research Network (NCI-EDRN) reported completion of the first phase of its development of a proteomics platform using Ciphergen's SELDI ProteinChip(R) System for the detection of prostate cancer. The study, which was published in the January issue of Clinical Chemistry, first measured the intra- and inter-laboratory reproducibility of serum profiling and then measured the inter-laboratory reproducibility of sample classification of blinded patient samples. In the study, 28 blinded samples were independently analyzed by each of six participating institutions, and each institution was able to correctly classify all 28 samples. The goal of the collaborative project was to use state-of-the-art protein profiling technology to develop and validate high-throughput screening methods for early detection of prostate cancer. The successful validation study of SELDI profiling included an initial phase to determine reproducibility of the SELDI assay as a specific response to questions of platform reproducibility. This was a necessary first step towards demonstrating the clinical viability of the assay. The study demonstrated that under standardized operating procedures (instrument calibration and standardization protocols), they were able to achieve across-laboratory reproducibility of SELDI-TOF-MS analysis. "Mass spectrometry is currently enjoying a renaissance period with potential application in clinical biomarker discovery and as a diagnostic tool. For the adoption of analytical instrumentation into a diagnostic platform and in discovery applications in which hundreds of samples are processed with the goal of identifying population specific protein changes, two essential qualities for a successful technology are reproducibility and portability. In this study, we established standard protocols in six laboratories that allowed each of six SELDI-TOF-MS systems to obtain 'identical' protein expression profiles when analyzing the same human serum sample. This result establishes for the first time that mass spectrometry, under the conditions utilized in this study, can result in reproducible output. These and other issues are slated to be examined in a multi-institutional collaboration funded by the NCI's Early Detection Network," stated O. John Semmes, Ph.D., Scientific Director, Virginia Prostate Center, Director, Center for Biomedical Proteomics and Associate Professor, Department of Microbiology and Molecular Cell Biology. "We are very excited about these promising results which demonstrate that SELDI-TOF-MS is reproducible and accurate when standardized operating procedures are followed similar to those followed in a CLIA certified laboratory. It is our ultimate goal to translate our biomarker discovery programs covering a range of life-threatening diseases into commercially viable diagnostic assays that could lead to earlier detection of disease and improved health outcomes," said Gail Page, President of Ciphergen's Diagnostics Division. Institutions participating in the NCI-EDRN study were: Department of Microbiology & Molecular Cell Biology, Virginia Prostate Center, Eastern Virginia Medical School; Fred Hutchison Cancer Center; Center for Prostate Disease Research, Department of Surgery, Uniformed Services University of the Health Sciences; University of Pittsburgh Cancer Institute, Hillman Cancer Center; Cancer Therapy and Research Center, Institute for Drug Development; Department of Pathology, Johns Hopkins Medical Institutes; Department of Pathology, University of Alabama at Birmingham; Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute; and Department of Medicine, University of Texas Health Sciences Center. About Ciphergen 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. Ciphergen's Biosystems Division develops, manufactures and markets a family of ProteinChip(R) Systems and services for clinical, research, and process proteomics applications. 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. 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 a future multi-institutional collaboration funded by the NCI's Early Detection Network, the use of ProteinChip technology to discover useful protein biomarkers that can act as novel drug targets or disease markers, develop and commercialize clinical diagnostics that improve patient care, the ability to provide services that lead to improved toxicology assays and diagnostic assays, and statements regarding 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 as novel drug targets, 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-Q dated November 9, 2004, 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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