Acute kidney injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days, which can be caused by severe dehydration or infections, medication toxicity, or major surgery. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs, and is common in patients who are in hospital intensive care units. Early detection is crucial to prevent progression and long-term harm.

ProNephro AKI (NGAL) is the first acute kidney injury biomarker test cleared for pediatric use (ages 3 months through 21 years) in the US. The technology originated out of Dr. Jonathan Barasch’s lab at Columbia University Irving Medical Center and is licensed to BioPorto through Columbia Technology Ventures, the tech transfer office of Columbia University. 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 during their first day in the intensive care unit (ICU). The test is a direct real-time marker that can detect kidney damage days earlier than the commonly used serum creatinine blood test. ProNephro AKI (NGAL) provides an additional data point for clinicians to identify AKI earlier and confidently make complex and potentially life-saving care decisions.
ProNephro AKI (NGAL) has FDA 510(k) marketing clearance on Roche’s cobas® c 501 analyzers, a fully automated clinical chemistry analyzer for in vitro tests used in hospital clinical laboratories.
BioPorto will continue expansion efforts through education and awareness programs targeting U.S. clinicians and researchers at major scientific nephrology and critical care conferences and scientific forums while Roche advances its efforts to connect with laboratory professionals at events such as the recent congress of the Association for Diagnostics & Laboratory Medicine.
ProNephro AKI (NGAL) product line expansion continues with the next major milestones including:
- Expansion of ProNephro AKI (NGAL) to additional standard lab chemistry instrumentation
- First patient enrollment in the study validating the use of ProNephro AKI (NGAL) in adults, on route to obtaining FDA clearance for the ProNephro AKI (NGAL) test for patients 22+ years of age.
As ProNephro AKI (NGAL) continues to expand, its impact is expected to grow across both pediatric and adult care. Ongoing efforts to broaden availability on additional laboratory platforms and to validate use in adult patients signal a clear path forward. By giving clinicians earlier, more reliable insight into kidney injury, this technology has the potential to shift how AKI is detected and managed—helping care teams act sooner, reduce complications, and improve outcomes for some of the most vulnerable patients.
This story was originally published in 2026.