BioPorto A/S has marked a pivotal milestone with the initiation of U.S. commercialization of its ProNephro AKI™ (NGAL) diagnostic test, designed to support early risk stratification of moderate-to-severe acute kidney injury (AKI) in pediatric patients. The test utilizes neutrophil gelatinase-associated lipocalin (NGAL), a clinically validated biomarker known to detect kidney stress and damage significantly earlier than traditional markers like serum creatinine. This innovative solution is FDA 510(k)-cleared for use on Roche’s cobas® c501 analyzer platform, a widely deployed system in U.S. hospital laboratories, ensuring immediate compatibility and streamlined implementation.

The clinical utility of ProNephro AKI lies in its ability to provide actionable insights at a critical juncture, particularly in pediatric care where early intervention is vital. With its application targeted at patients aged 3 months to 21 years, the test enables physicians to identify at-risk individuals sooner, allowing for timely therapeutic decisions, better fluid management, and improved outcomes. Through its partnership with Roche Diagnostics, BioPorto can extend access to hospitals and laboratories across the country, reinforcing the test’s scalability and potential for rapid adoption.

This first commercial order in the U.S. not only validates market readiness but also underscores the test’s importance in addressing a high-need area of diagnostic medicine. As healthcare systems increasingly prioritize early detection and precision diagnostics, ProNephro AKI emerges as a critical tool in the clinical workflow. Its launch supports BioPorto’s long-term strategy of enhancing kidney health diagnostics and represents a step forward in improving care quality and efficiency in pediatric nephrology.