The collaboration marks the first major commercial step to advance adoption of ProNephro AKI across US hospital institutions.
BioPorto A/S announced that its ProNephro AKI (NGAL) test for acute kidney injury is now commercially available to US laboratories through the company’s collaboration with Roche Diagnostics. The test has FDA 510(k) marketing clearance on Roche’s cobas c 501 analyzers, fully automated clinical chemistry analyzers used in hospital clinical laboratories.
ProNephro AKI (NGAL) represents the first acute kidney injury biomarker test cleared for pediatric use in patients ages 3 months through 21 years in the US, according to a release from BioPorto. The test is designed to help physicians identify patients at risk of developing or having persistent moderate-to-severe AKI within 48 to 72 hours during their first day in the intensive care unit.
NGAL serves as a direct real-time marker of kidney cell damage that can detect kidney damage days earlier than serum creatinine. Early detection of AKI may enable prompt intervention, providing clinicians with an additional data point to identify AKI earlier and make potentially life-saving care decisions.
“We have crossed another significant milestone in our journey building a commercial platform for kidney diagnostics,” says Jennifer Zonderman, BioPorto’s senior vice president of global marketing and commercialization, in a release. “The company’s go-to-market strategy leverages strong research and publications around NGAL which have created high customer interest and have been well received by clinicians in the field.”
Risk Stratification Capabilities
The test’s risk stratification claim allows clinicians to identify patients with both low risk and high risk of moderate to severe AKI, supporting personalized medicine approaches for kidney care. This capability addresses what BioPorto describes as pent-up demand for ProNephro AKI in the shared customer base with Roche.
BioPorto plans to continue expansion efforts through education and awareness programs targeting US clinicians and researchers at major scientific nephrology and critical care conferences. Meanwhile, Roche will advance efforts to connect with laboratory professionals at events such as the recent ADLM congress.
BioPorto, based in Copenhagen, Denmark, and Boston, Massachusetts, focuses on developing actionable kidney biomarkers designed to help clinicians make changes in patient management. The company’s flagship products are based on the NGAL biomarker and designed to aid in risk assessment and diagnosis of acute kidney injury.
The company markets NGAL tests under applicable registrations including CE mark in several countries worldwide and the FDA-cleared ProNephro AKI (NGAL) for pediatric use in the US.
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