Second Study Supports that NGAL Test Identifies Acute Kidney Injury Early in Critically Ill Patients

According to a recent study published in Intensive Care Medicine, a novel bedside blood test measured in critically ill patients being admitted to the intensive care unit can help to identify which patients are at risk for acute kidney injury (AKI). The study carried out in Vicenza, Italy, tested blood samples collected during admission to the ICU using the Triage® NGAL Test, a product currently sold by Inverness Medical Innovations, Inc. (NYSE: IMA) outside of the United States.*

AKI is a common and often devastating complication for up to 25% of critically ill patients admitted to the ICU. AKI can lead to increasing hospital length of stay and associated costs, and also increases risk of death. AKI is often detected too late into its clinical progression when a substantial portion of kidney function may already have been lost and the window for initiating treatment to prevent further harm has closed.

A small study conducted in early 2009 at the University Hospital of Clermont-Ferrand, France and published in the Journal of Critical Care found that a new bedside blood test for a blood biomarker called neutrophil gelatinase-associated lipocalin (NGAL) offered the promise of rapidly assessing if a critically ill patient is suffering from AKI. Now results from the prestigious Department of Nephrology at San Bortolo Hospital in Vicenza Italy have confirmed these findings in a larger study published this week in Intensive Care Medicine.

In this study of 301 critically ill patients, plasma NGAL measured with the Triage NGAL Test was a statistically significant diagnostic marker for AKI development within the next 48 hours (area-under-ROC 0.78), and for renal replacement therapy use (area-under-ROC 0.82). Moreover, peak plasma NGAL concentrations increased with worsening AKI severity (R=0.554, p<0.001).

“We are living in an exciting era where it seems possible to diagnose AKI much earlier than before thanks to NGAL, a new promising biomarker of kidney damage. This may contribute to have a diagnosis in place, especially in the area of critically ill patients where an early detection of kidney insult may allow to stop harmful interventions or to install preventive /protective therapies that before were precluded or not indicated.” said Prof. Claudio Ronco of the San Bartolo Hospital in Vicenza where the study was conducted.

Inverness supplied the Triage NGAL Tests used in the study at no charge, but did not otherwise fund or sponsor the study.

*The Triage NGAL Test is not currently available for purchase or use in the United States.