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Across the Lone Star State, Medical Researchers Are Developing a New Generation of Diagnostic Tests

Posted on: Wednesday, 6 July 2005, 09:00 CDT

AUSTIN, Texas, July 6 /PRNewswire/ -- In the international race to find more accurate and reliable ways of detecting serious diseases, the major medical research institutions in Texas are at the forefront of what is pointing to a major transformation in medical diagnostics.

A cluster of medical centers across the Lone Star State ranging from the MD Anderson Cancer Center and Texas Children's Hospital in Houston, to the University of Texas Medical Branch in Galveston, the University of Texas Medical Center in Dallas, and the CRTC Institute for Drug Development in San Antonio, are working on developing a variety of different tests based on the body's proteins.

The researchers are rapidly exploring hundreds of proteins often in a single blood sample in their quest to identify which ones can be used to detect a specific disease such as breast or ovarian cancer. Although the research goals vary dramatically from institution to institution, each of these teams is using a research technology, called SELDI, from Ciphergen Biosystems Inc. of Fremont, CA (CIPH). Their efforts are aided by the Austin- based President of Ciphergen's Diagnostics Division, which is coordinating an international effort to turn laboratory findings into doctor-ordered diagnostic tests with the highest degree of reliability. A common goal for many of these forthcoming diagnostic tests is to identify if a patient has early signs of a specific disease -- even before the traditional symptoms have appeared -- and provide an initial prognosis for recovery.

"Texas has long been a mecca for cancer research," said Gail Page, President of Ciphergen's Diagnostics Division. "What people may not realize is that our state is at the leading edge of many different aspects of medical research. I am proud to add that Ciphergen's SELDI system is a major tool for research efforts supporting the emerging field of biomarker discovery in protein-based diagnostics."

Biomarkers are proteins or other molecules whose levels or other characteristics are changed in a specific disease. Biomarkers can be used clinically as reliable indicators of disease presence or progression and as potential predictors of how patients will respond to a particular medicine. Researchers are examining how using combinations of biomarkers, often called molecular signatures or biomarker patterns, can more accurately describe a patient's status and pave the way for personalized medicine.

Using SELDI -- short for Surface Enhanced Laser Desorption/Ionization -- to detect proteins captured on ProteinChip(R) Arrays along with advanced software enables researchers to rapidly find and sort through many proteins found in serum. With a single blood sample, researchers can discover changes in proteins that are present in people with a specific disease such as ovarian cancer, versus people without disease.

Among Ciphergen's key collaborations: * MD Anderson Cancer Center in Houston. Researchers are studying distinctive biomarker patterns to potentially detect both early stage ovarian cancer and predict patients' response to specific medical treatments. The research is led by Robert C. Bast, M.D., who developed CA125, currently the most widely used test for monitoring the recurrence, post treatment, of ovarian cancer. The research is being done jointly with Johns Hopkins School of Medicine. * CRTC Institute for Drug Development in San Antonio. Researchers here are working with colleagues at five other medical facilities to develop a better prostate cancer detection test. Such a test would potentially replace the often inaccurate PSA (prostate specific antigen) test that requires prostate biopsies, which are costly and invasive and also often miss the disease. An estimated 232,000 men in the U.S. will be diagnosed with prostate cancer this year. "Two key goals of a proposed prostate cancer diagnostic exam are better prognosis for patients, as early-stage prostate cancer is a treatable disease with a high cure rate, and reducing unnecessary biopsies from men with marginally elevated PSA levels," noted Elzbieta Izbicka, Ph.D. Director of Biomarkers and Biomedical Proteins at the Institute for Drug Development. * University of Texas Medical Branch, Galveston. The goals of the research are to develop a Hepatitis C blood test to better determine a more precise course of treatment based on a patient's stage of liver fibrosis and thus minimize the number of liver biopsies. An estimated four million Americans are infected with Hepatitis C which typically attacks the liver for decades before symptoms develop. When they do appear, biomarker tests might also rule out other liver diseases and detect different levels of liver fibrosis, as well as be sensitive to changes in fibrosis induced by therapy or the natural history of disease progression, noted John Petersen, Ph.D., Professor of Pathology and Ned Snyder, M.D., Professor of Internal Medicine, who are leading the research team. * Texas Children's Hospital, Houston. Developing a biomarker that could distinguish which group of adolescents just diagnosed with bone cancer would not respond well to chemotherapy -- the current standard of care given to all osteosarcoma patients prior to surgery -- might enable doctors to develop an alternative drug therapy and improve their care. For children with brain tumors, researchers led by Ching Lau, Associate Professor of Pediatrics at nearby Baylor College of Medicine, are studying protein biomarkers in cerebrospinal fluid instead of blood to initially distinguish between benign and cancerous tumors and then go on to the next step to determine the degree of malignancy and how it is responding to drug treatment. * University of Texas Medical Center in Dallas. Researchers are studying a range of medical issues affecting pregnant women with pre-term delivery problems. By examining maternal blood biomarkers, they hope to better predict which women are at risk of going into pre-term labor and those who will deliver at full term. "Working with blood samples collected from Parkland Hospital, where 16,000 babies are born annually, plus blood samples from Asian Pacific Islanders, scientists are hoping to find neonatal biomarkers that identify genetic abnormalities in early pregnancies," noted Kevin Rosenblatt, Assistant Professor of Pathology.

Still other researchers in the University of Texas system are using SELDI technology to find biomarkers that can potentially detect deadly infectious diseases such as hemorrhagic fever, West Nile virus, and other flavi and arena viruses as part of the nation's biodefense program.

"Within the UT (University of Texas) system, we view SELDI as one of our important tools for finding biomarkers that down the road will be utilized for diagnostic tests in disease identification, detection and eventually for treatment," said David Gorenstein, Ph.D., Associate Dean for Research at the School of Medicine of the University of Texas Medical Branch at Galveston. "As we begin to look at the whole constellation of proteins rather than selective members, we see pharmacoproteomics as the future and have made major investments in mass spectrometers and proteomics."

For more information contact: Ronald Rosenberg at Lehman Millet, 60 Canal Street, Boston, MA 02114 617-722-0019 ronald_rosenberg@millet.com 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 Centers(R) 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 the use of Ciphergen's SELDI technology to discover biomarkers that can be useful as diagnostics in a variety of cancers and other medical conditions, the diagnostic tests that Ciphergen Diagnostics is developing, the predictive diagnostic value of protein biomarkers, and the expectation that protein multi-marker tests will improve patient care. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the ProteinChip technology's ability to successfully discover, validate and assay biomarkers and patterns of biomarkers that have diagnostic utility, and Ciphergen's ability to protect and promote its proprietary technologies. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-Q dated May 10, 2005, for further information regarding these and other risks of the Company's business.

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

Ciphergen Biosystems Inc.

CONTACT: Ronald Rosenberg at Lehman Millet, +1-617-722-0019,ronald_rosenberg@millet.com

Web site: http://www.ciphergen.com/

Source: PRNewswire

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