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Novel Diagnostic Marker for Acute Kidney Injury Previewed at Abbott-Sponsored Scientific Workshop
Date:7/29/2008

Data Presented at American Association for Clinical Chemistry (AACC) Meeting Show Urine NGAL Can Potentially Save Lives by Enabling Faster

Detection of Acute Kidney Injury

WASHINGTON, July 29 /PRNewswire-FirstCall/ -- A new diagnostic marker, called urine NGAL, for early detection of acute kidney injury (AKI) in hospitalized patients can distinguish AKI from other forms of kidney dysfunction and save lives by preventing kidney failure, according to research presented today at the American Association for Clinical Chemistry (AACC) annual meeting.

The research was presented by Prasad Devarajan, M.D., director of nephrology and hypertension, Cincinnati Children's Hospital Medical Center, at a scientific workshop hosted by Abbott.

AKI is a common and potentially devastating illness in hospitalized patients. Onset is rapid and can result from trauma, sepsis or administration of medications toxic to the kidneys. AKI can also present following cardiothoracic surgery or as a complication of diabetes and other chronic conditions. AKI quickly reduces the ability of the kidneys to filter waste and leads to renal failure. Many patients with a severe form of AKI face extensive time on dialysis. The mortality rate for patients with AKI ranges up to more than 80 percent in post-operative settings, according to a study reported recently in the Annals of Internal Medicine.

"Unfortunately, the current testing procedure for AKI -- a blood test to measure the ability of the kidneys to filter creatinine into the urine -- is unable to identify the problem in the first 48 hours when time is critical for preventing kidney failure," said Dr. Devarajan. "The incidence of this common complication has risen by 11 percent in recent years, and we need better ways to diagnose and treat the condition and lower the risk of death or needing dialysis," he said.

Devarajan reported today the results of clinical studies conducted for a new diagnostic biomarker for acute AKI, called urine NGAL (neutrophil gelatinase-associated lipocalin). The protein is produced by the kidney tubules and appears in urine just two to four hours following AKI, up to 46 hours sooner than biomarkers detected by current testing methods.

"The urine NGAL marker has the potential to represent a major advance in identifying patients at risk for developing AKI after surgery or trauma and in other situations commonly seen in critically ill patients," Devarajan said. He noted that delayed diagnosis of AKI with currently-used creatinine tests may prevent physicians from using hydration or blood pressure support in a timely manner to lower the risk for patient harm.

The costs of AKI are a substantial $10 billion a year, mainly from lengthy hospital stays and expensive interventions, according to Chirag Parikh, M.D., Ph.D., associate professor of medicine, Yale University Medical School. "Serum creatinine testing is inadequate. It is a non-specific marker that delays diagnosis of AKI. New biomarkers are needed to stimulate testing of new therapies and significantly decrease the mortality in AKI and costs associated with it," he said.

In his research, Devarajan analyzed urine samples from children with congenital heart defects who had cardiopulmonary bypass surgery. The procedure is a major risk factor for AKI. Half of the children developed AKI, based on results of creatinine tests reported two to three days after surgery. However, their NGAL levels began to increase within a few hours. "Rises in urine NGAL levels at two hours identified 90 percent of children who later developed AKI. Urine NGAL, therefore, was highly predictive of AKI risk, and we found those with higher levels were more likely to die or need dialysis," Devarajan said. He added that these findings have been confirmed in adult populations.

About 65 percent of patients with the highest increase in urine NGAL will require immediate care by a nephrologist and a third will go on dialysis. "Clinically, there is no comparison since NGAL provides specific and rapid diagnosis of AKI while creatinine blood tests are not able to distinguish AKI from chronic kidney disease," Devarajan said.

"From the single drop of urine, we obtain essential information when time is critical to help prevent kidney failure and save lives. With close monitoring, the early information provided by the NGAL test could make treatments more effective if started at the beginning of AKI," he said.

Devarajan presented his findings during a symposium at AACC titled Translational Medicine and the Clinical Laboratory: Emerging Biomarkers for Acute Kidney Injury. The marker has been the subject of recent articles published in Lancet, Annals of Internal Medicine and the Clinical Journal of the American Society of Nephrology. Devarajan's research was supported, in part, by a restricted research grant from Abbott.

Abbott is developing a unique urine NGAL test and has initiated international clinical trials.

About Abbott's Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 65,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs. Abbott's history is filled with examples of first-of-a-kind diagnostic products and significant technological and research advancements.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.


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