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Urinary Biomarkers Identify First Signs of Kidney Failure in Patients Undergoing Open Heart Surgery CINCINNATI, June 28 /PRNewswire/ -- A Cincinnati medical research team led by Prasad Devarajan, MD, has reported discovering a series of early biomarkers in urine that may dramatically reduce from 3 days to two hours, the ability to identify the first signs of potential kidney failure in patients undergoing open heart surgeries. Their research, entitled "Early Prediction of Acute Renal Injury Using Urinary Proteomics," was just published online in The American Journal of Nephrology (2005; 25:318-326). They studied 60 children and young adults undergoing cardiopulmonary bypass operations, according to Dr. Devarajan, The Louise M. Williams Endowed Chair, Professor of Pediatrics and Developmental Biology, and Director of Nephrology and Hypertension at Cincinnati Children's Hospital Medical Center. Biomarkers are proteins found in blood, saliva or urine, that signal the presence of disease. They are at the center of proteomics, a new growing field involved in the study of all proteins in an organism. In their paper, the researchers reported identifying four distinct urinary biomarkers that predict acute renal injury using recent advances in proteomics with proprietary technology from Ciphergen Biosystems, Inc (NASDAQ:CIPH). The biomarkers detected with the Ciphergen equipment were also confirmed by more conventional methods, prompting Dr. Devarajan and the group to note that this advanced technology which detects proteins captured on protein biochips has emerged as the preferred platform for urinary protein profiling. "Despite major achievements in treating patients with kidney failure, little has changed in the last four decades to enable early diagnosis of kidney failure before it progresses to a potentially deadly condition," said Dr. Devarajan who cited, in the research paper, that the Ciphergen method is rapid, enabling researchers to identify the key proteins in urine with a turn- around time of only 90 minutes, and requiring only a microliter of urine. More than 700,000 patients undergo cardiopulmonary bypass operations annually in the US alone, with up to 40 percent of them experiencing some degree of acute renal failure -- considered a common and potentially devastating problem in clinical medicine. Similarly, 10 percent of infants and children with congenital heart disease also experience acute renal failure following cardiac surgery, to the point where they require dialysis for survival. By identifying the first signs of kidney problems following surgery in a matter of hours, physicians can launch potentially effective therapeutic measures immediately. Currently, doctors measure changes in serum creatinine, a waste product of protein metabolism found in muscle and blood and excreted in normal urine. However, evaluating creatinine levels in the blood is considered an unreliable indicator of sharp changes in kidney function. The Cincinnati researchers noted that everyone in the study started with normal kidney function and similar urinary proteomic patterns. But for 25 percent of the group, their cardiac operations led to acute renal failure, that was predictable based on each of their biomarker patterns. Of the 60 participants, who each provided a series of spot urine samples before their surgery and two hours and six hours after their operations, researchers found that 15 subsequently developed acute renal failure. This group had a 50 percent or greater increase in serum creatinine after their operations. Five of the 15 had elevated serum creatinine within the first two days after their operations while the other 10 experienced similar problems 48 to 72 hours after surgery. In striking contrast, all patients who subsequently developed acute renal failure revealed characteristic changes in their urine biomarker patterns within two hours of the surgery. "In addition to cardiac surgery patients, this method and test could be very useful in the early diagnosis and prediction of kidney injury in a variety of other common clinical situations, including kidney transplantation, abdominal surgery, trauma, bleeding, shock, myocardial infarction, stroke, sepsis, and the use of nephrotoxic medications such as antibiotics and chemotherapy," said Dr. Devarajan. For more information about the study contact: Amy Reyes, Media Relations Manager Cincinnati Children's Hospital Medical Center 513-636-9684 For more information about Ciphergen Biosciences, Inc., contact: Ronald Rosenberg Lehman Millet 60 Canal Boston, MA 02114 617-722-0019 x 3275 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 an early predictor of kidney failure or other 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 with respect to kidney failure or other medical conditions, 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. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: Amy Reyes, Media Relations Manager of Cincinnati Children's Hospital Medical Center, +1-513-636-9684, ; or Ronald Rosenberg for Ciphergen Biosciences, Inc., +1-617-722-0019 ext. 3275, Web site: http://www.ciphergen.com/

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