FDA accepts for review Abbott's novel diagnostic test for rapid detection of NGAL

A novel diagnostic test to rapidly detect neutrophil gelatinase-associated lipocalin (NGAL), an early biomarker that identifies patients at risk for acute kidney injury (AKI), has been accepted for review by the United States Food and Drug Administration. If approved, this would be the first test available for use in the United States for the detection of NGAL.

With the help of a new diagnostic test that can aid in detecting NGAL, physicians can significantly reduce the risk of AKI by using simple measures such as hydration or blood pressure support to lower the risk of harm," said Sudarshan Hebbar, M.D., medical director, Abbott Diagnostics.

Abbott's test would be able to detect NGAL about two days earlier than the most widely used method for the detection of AKI, a serum creatinine blood test. A landmark study published in Annals of Internal Medicine in May 2008, reported that NGAL is a highly sensitive and specific test for differential diagnosis of AKI that helps distinguish acute injury from normal function and chronic kidney disease.

From the single drop of urine, we obtain vital information when time is critical to improve patient management. Early information provided by an NGAL urine test could make treatments more timely and effective and reduce costs due to early intervention," said Dr. Hebbar.

The new Abbott test received CE Mark certification in Europe last year and is being used by nephrologists and other physicians in the European Union. It is currently an investigational device in the United States. Abbott's Urine NGAL assay is performed on the company's flagship automated laboratory instrument, the ARCHITECT system.




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