Skip to main content
Premium Trial:

Request an Annual Quote

Bioporto Acute Kidney Injury Test Nabs FDA Clearance

NEW YORK – Danish diagnostic firm Bioporto announced on Friday that its test for acute kidney injury in hospitalized children has received clearance from the US Food and Drug Administration.

The ProNephro AKI test is intended to assess the risk of moderate to severe acute kidney injury in hospitalized children between 3 months and 21 years of age. The assay measures the biomarker neutrophil gelatinase-associated lipocalin (NGAL), a marker of kidney cell damage that can detect acute kidney injury earlier than the current standard of care, serum creatinine measurement, the company said in a statement. 

"Widespread NGAL measurement in pediatric settings will give clinicians greater confidence in making treatment decisions, which can save lives, shorten hospital stays, and ensure that fewer pediatric patients progress to costly and debilitating chronic kidney disease," Prasad Devarajan, Bioporto's senior medical director, said in a statement.