Innovation Ventures

Acute Kidney Injury Diagnostic

NGAL: Quick Detection, Better Care

Cincinnati Children’s achieved a major milestone with the first FDA-cleared pediatric test for acute kidney injury (AKI) in the U.S., targeting a life-threatening condition affecting one-third of critically ill children. The NGAL (Neutrophil Gelatinase-Associated Lipocalin) biomarker, discovered by Prasad Devarajan, MD, director of the Division of Nephrology and Hypertension and his team, detects AKI up to 72 hours earlier than traditional methods—a critical window to improve outcomes for patients in intensive care.

“We wanted to move the clock to as near the injury as possible,” said Devarajan, recalling circumstances 20 years ago when the research began. “The tools we had were imprecise and delayed. By the time traditional markers appeared, it was too late to intervene.”

After identifying NGAL’s potential, Cincinnati Children’s collaborated with BioPorto, an in vitro diagnostics company, to develop the test for clinical use. In partnership with BioPorto, Cincinnati Children's brought the NGAL-based ProNephro AKI test to market. 

In 2015, they launched a rapid-turnaround test that can be administered in any hospital worldwide. Devarajan describes the result as a test that “anyone at any hospital in the world can use.” With years of clinical data supporting its efficacy and two prospective multi-center studies led by Cincinnati Children’s, the FDA recently approved the NGAL test for pediatric patients nationwide, ages 3 months to 21 years.

“This approval is a significant milestone in pediatric care,” says Stuart Goldstein, MD, director of the Center for Acute Care Nephrology at Cincinnati Children’s. “Having an additional data point to assess a child’s risk of kidney injury will help physicians make complex and potentially life-saving decisions earlier and more confidently.”

Read more about the NGAL test, now providing hope to families and a critical tool to clinicians.