Abbott has signed an exclusive agreement with Cincinnati Children’s Hospital to develop a urine-based diagnostic assay to detect kidney injury and disease using the protein neutrophil gelatinase-associated lipocalin (NGAL). NGAL is a biomarker that has been reported to be valuable in assisting physicians in rapidly and accurately diagnosing acute kidney failure in a matter of hours compared to current tests that may take up to several days.

“We are excited to begin our work in developing a test that may help clinicians addresss kidney failure much earlier and with greater precision,” says William Brown, PhD, vice president, diagnostic assays and systems development at Abbott. “When available, this will be an important addition to our menus, and represents the cutting edge diagnostic science that laboratory customers expect from Abbott.”

Acute kidney failiure is present in 5% of all hospital admissions and in up to 30% of those patients in intensive care units. When advanced kidney failure is observed in the intensive care unit, mortality rates of 40 to 80% have been reported. The cost of treating advanced kidney failure in the intensive care unit is about $50,000 per patient.

“Early identification of acute kidney failiure is the key to helping physicians manage and treat the condition more effectively,” says Prasad Devarajan, MD, director of the division of nephrology and hypertension at Cincinnati Children’s Hospital Medical Center. “Developing effective, accurate, and reliable diagnostic tests for this condition will significantly improve patient health and lower deaths.”

A study in the April 2005 edition of The Lancet reported that concentrations of NGAL were “strikingly raised” in the urine and serum of children with acute kidney failure after undergoing cardiopulmonary bypass surgery. In addition, a study published in the May 2006 edition of the American Journal of Transplantation reported that NGAL may be used to predict kidney failure in patients following kidney transplantation.

“The work carried out by Dr. Devarajan represents a pioneering effort to move medicine into a more individualized and prospective mode,” says Tom Boat, MD, chairman of pediatrics and director of the Cincinnati Children’s Research Foundation. “Called ‘predictive medicine,’ this approach to care should improve health outcomes and reduce costs by providing critical information in a more timely fashion.”