Ciphergen Biosystems, Inc. (CIPH) - 500 Beiträge pro Seite

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Profile:Ciphergen Biosystems, Inc. develops, manufactures and markets ProteinChip Systems, which use Surface Enhanced Laser Desorption/Ionization (SELDI) technology. The ProteinChip Systems enable protein discovery, characterization and assay development to provide researchers with a better understanding of biological functions at the protein level. Ciphergen`s ProteinChip Systems integrate the key steps of proteomics research on a single, miniaturized biochip. The ProteinChip Systems incorporate SELDI technology on the surface of a consumable biochip, which allows researchers to capture and analyze proteins directly. The ProteinChip Systems enable rapid, reproducible, on-chip protein expression and protein analysis from complex biological samples, such as whole blood, tissue or saliva, without separation, tagging and amplification processes and with minimal prior purification.
http://www.ciphergen.com

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Promising Results for Detection of Early Stage Ovarian Cancer Published in Cancer Research Journal
Monday August 16, 8:03 am ET
Discovery of Biomarkers and Development of Multi-Marker Assay Enabled by Ciphergen`s ProteinChip(R) System


FREMONT, Calif., Aug. 16 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (Nasdaq: CIPH - News) announced today the discovery of biomarkers and development of a multi-marker pattern assay that shows promising results in the detection of early stage ovarian cancer. The study, performed in collaboration with Ciphergen`s Biomarker Discovery Center® and the Johns Hopkins School of Medicine published in today`s issue of Cancer Research, describes the use of Ciphergen`s ProteinChip System to discover three protein biomarkers that, when combined, form the basis of a clinical assay designed to detect stage I/II ovarian cancer. Each of the three proteins has been sequenced and identified with the use of the ProteinChip System; two of these novel biomarkers are cleaved products of precursor proteins and present in the serum at a fraction of the concentration of their corresponding full-length proteins. This study examined 503 patients and employed a multi-institutional study design, with both cross-validation and independent validation of the individual biomarkers as well as of the multi-marker pattern. The pattern of three biomarkers was able to diagnose early stage (I/II) ovarian cancer with 74% sensitivity at 97% specificity.
The study reported in Cancer Research utilized Ciphergen`s SELDI-based ProteinChip System to generate protein expression profiles from serum obtained from 503 women with ovarian cancer, benign pelvic disease, or who were healthy. The samples were obtained from four hospitals, and a rigorous cross-validation and independent validation study design was employed. A sophisticated bioinformatics program was used to discover the three biomarkers and to generate a multi-marker pattern. The combined improvement in sensitivity and specificity is reflected in the higher area under the curve (AUC) of the receiver operator characteristic (ROC) for the three marker pattern (AUC = 92%). The study included purification and identification of the three markers, believed to be host response proteins, two of which had undergone post-translational modifications. The markers were a processed form of ITIH4, a truncated form of transthyretin, and apolipoprotein A1. Changes in transthyretin and apolipoprotein were independently validated in ovarian cancer samples from a fifth hospital using a traditional immunoassay.

"Because of the rigorous multi-institutional study design and the use of independent validation, we believe these results are more likely to be reproducible and therefore translated to clinical practice," said Robert Bast, M.D., Vice-President of Translational Medicine at MD Anderson Cancer Center and co-author on the paper. "Diagnosis of early stage ovarian cancer could play a critical role in decreasing the mortality from this disease. Ongoing work is being conducted to evaluate how these markers should be used in conjunction with other tests to achieve this goal."

Approximately 23,000 new cases of ovarian cancer are diagnosed in the United States each year, and there are over 14,000 deaths from ovarian cancer each year. The high mortality is a result of the fact that most women are diagnosed with late stage ovarian cancer (III or IV). When ovarian cancer is diagnosed in its earlier stages (I or II), the cure rate approaches 80%. Therefore, a diagnostic test that can detect early stage ovarian cancer would be highly desirable. CA125, the only currently available tumor marker for ovarian cancer, has a sensitivity of approximately 30-50% for stage I/II ovarian cancer and is approved only for monitoring for recurrence after treatment.

"We are excited by these results and also to have licensed the test from Johns Hopkins in preparation for commercialization," stated Gail S. Page, President of Ciphergen`s Diagnostics Division. "We are currently validating these promising results in a 1500 sample trial and developing SELDI-based assays as part of our commercialization strategy."

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® 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® 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. Additional information about Ciphergen can be found at ww.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 utility of these biomarkers for the detection of early stage ovarian cancer, the likelihood that the results of the study can be reproduced, 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 possibility that the biomarker panel described in this publication or any other biomarker panel discovered by Ciphergen may fail to validate in larger studies as providing an accurate diagnostic for ovarian cancer, 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 August 9, 2004, for further information regarding these and other risks of the Company`s business.

NOTE: Ciphergen, ProteinChip, Biomarker Discovery Center and BioSepra are registered trademarks of Ciphergen Biosystems, Inc.




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Source: Ciphergen Biosystems, Inc.