FDAnews
www.fdanews.com/articles/125856-abbott-applies-for-fda-approval-of-rapid-aki-diagnostic

Abbott Applies for FDA Approval of Rapid AKI Diagnostic

March 31, 2010
The FDA has accepted Abbott’s application for the first diagnostic in the U.S. to detect neutrophil gelatinase-associated lipocalin, a biomarker to identify patients at risk for acute kidney injury (AKI), the company says. The test would detect the biomarker two days sooner than the serum creatinine blood test currently used to diagnose AKI. Abbott’s test received a CE Mark last year in the EU and is currently an investigational device in the U.S.