US pharma Abbott has announced it has received CE Marking (Conformité Européene) for a new diagnostic test for acute kidney injury (AKI). The test detects an important protein in urine, neutrophil gelatinase-associated lipocalin (NGAL), an early marker or indicator for AKI.
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CE marking certifies that a product has met EU consumer safety, health or environmental requirements.
NGAL is a novel biomarker that can be detected in urine in as little as two hours instead of days. Early detection can aid in the diagnosis of AKI - a common condition that can quickly progress to kidney failure if left untreated - and help physicians better manage patient care. Current tests lack the clinical and timely precision that can help physicians intervene quickly and mitigate the effect of any potential injury.
AKI is a common and often devastating illness that quickly reduces the ability of the kidneys to filter waste, a condition which can then progress to kidney failure. Common causes of AKI include sepsis, major surgery, cardiogenic shock, trauma and medications toxic to the kidneys. Prompt diagnosis of AKI is critical in reducing mortality, which is as high as 80 percent in post-operative settings. In addition, AKI predisposes those surviving to an increased incidence of chronic kidney disease and end-stage renal disease
''Earlier and more accurate differential diagnosis of evolving AKI could result in quicker changes in patient management to make potentially life-saving therapeutic interventions and stop harmful progression,'' said Patrick Murray, M.D., professor, University College Dublin and Mater Misericordiae University Hospital.