BioPorto A/S announced receipt of a US Food and Drug Administration (FDA) 510(k) clearance for BioPorto?s NGAL test, to be marketed as ProNephro AKITM (NGAL). ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker test cleared for pediatric use (aged 3 months through 21 years) in the US. ProNephro AKI (NGAL) is designed to help doctors identify patients at risk of developing or having persistent, moderate-to-severe AKI within 48-72 hours in the intensive care unit (ICU) setting.

Unlike serum creatinine, a muscle by-product that is the current standard of care but slow to rise in AKI, NGAL is a direct real time marker of kidney cell damage and can potentially detect AKI days earlier than serum creatinine. Early detection of AKI may enable prompt intervention to save lives. Until now, the risk for developing or having persistent AKI has been difficult to assess early because current standard-of-care methods, such as sCr, rise slowly in AKI.

As such, ProNephro AKI (NGAL) was developed to help save kidneys and lives through faster and more timely intervention.