COPENHAGEN, DENMARK and BOSTON, MA — August 28, 2025 — Leads & Copy — BioPorto A/S (CPH:BIOPOR) has announced that ProNephro AKI (NGAL), its test for acute kidney injury, is now commercially available to US laboratories through a collaboration with Roche Diagnostics. The test has FDA 510(k) marketing clearance on Roche’s cobas® c 501 analyzers.
ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker test cleared for pediatric use (ages 3 months through 21 years) in the US. It helps doctors identify patients at risk of developing moderate-to-severe AKI within 48-72 hours during their first day in the ICU. NGAL detects kidney damage earlier than serum creatinine, potentially enabling prompt intervention to save lives.
BioPorto’s SVP of Global Marketing & Commercialization, Jennifer Zonderman, stated that this milestone leverages strong research and publications around NGAL, which have created high customer interest. The company will continue expansion efforts through education and awareness programs, while Roche connects with laboratory professionals.
Future milestones include expanding ProNephro AKI (NGAL) to additional standard lab chemistry instrumentation and first patient enrollment in the study validating its use in adults.
Jennifer Zonderman, BioPorto, SVP of Global Marketing & Commercialization, +1 617 694 2918, jmz@bioporto.com
Hanne Foss, BioPorto, Head of Investor Relations, +45 4529 0000, investor@bioporto.com
