Denmark-based in-vitro diagnostics company BioPorto has announced the commercial launch of its ProNephro AKI test in the US, through collaboration with Roche Diagnostics.
The commercial launch of the ProNephro AKI test, designed for early detection of acute kidney injury (AKI), marks a significant step towards its adoption in US hospital laboratories.
The collaboration is designed to facilitate integration into clinical settings using Roche’s cobas c 501 analysers.
According to BioPorto, ProNephro AKI is the only AKI biomarker test cleared for pediatric use in the US, serving patients aged three months to 21 years.
It helps in identifying those at risk of moderate-to-severe AKI within 48 to 72 hours of admission to intensive care (ICU).
The test detects kidney damage earlier than traditional methods, enabling timely medical intervention.
BioPorto global marketing and commercialisation SVP Jennifer Zonderman said: “We have crossed another significant milestone in our journey building a commercial platform for kidney diagnostics.
“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.
“The risk stratification claim allows clinicians to identify those with low risk as well as those with high risk of moderate to severe AKI, initiating personalised medicine for the kidney.
“Looking ahead to the rest of 2025, we are pleased to address the pent-up demand for ProNephro AKI in the shared customer base.”
BioPorto is set to expand awareness and usage of the test through educational initiatives targeting clinicians and researchers.
Its efforts will be complemented by Roche’s engagement with laboratory professionals.
The company also plans to widen the test’s compatibility with additional lab equipment and begin adult-focused validation studies.
Recently, BioPorto secured FDA marketing clearance for the pediatric use of NGAL tests and established a distribution agreement with Beckman Coulter.
The partnership will initially target European markets, with US distribution contingent on further FDA approvals for Beckman Coulter’s platforms.
