BioPorto A/S announced the initiation of commercial sales for its ProNephro AKI (NGAL) diagnostic test in the United States, marking a significant milestone in the company's expansion into the American kidney diagnostics market. The Danish in vitro diagnostics company received its first purchase order for the test, which will be distributed to US hospitals through its partnership with Roche Diagnostics.
FDA-Cleared Diagnostic for Pediatric and Young Adult Patients
ProNephro AKI (NGAL) has received FDA 510(k) marketing clearance for clinical use in risk stratification for moderate-to-severe acute kidney injury (AKI) in patients aged 3 months to 21 years. The test runs on Roche's cobas c501 analyzers, which are broadly available in standard medical laboratories and hospitals across the United States.
The diagnostic leverages neutrophil gelatinase-associated lipocalin (NGAL) biomarker technology to aid physicians in identifying patients potentially at risk of AKI more rapidly than current standard of care measurements. This enhanced detection capability enables earlier intervention and more tailored patient management strategies for a condition that can have severe consequences, including significant morbidity and mortality, if not identified and treated promptly.
Strategic Partnership Enables Market Access
The commercialization effort is facilitated through BioPorto's distribution relationship with Roche Diagnostics, providing access to the extensive network of hospitals and laboratories that utilize Roche's analyzer platforms. This partnership strategy allows BioPorto to leverage existing infrastructure rather than building independent distribution channels.
Peter Mørch Eriksen, BioPorto's Group Chief Executive Officer, emphasized the significance of this development: "As previously mentioned in the Company's reporting and investor communications, the launch of ProNephro AKI (NGAL) in the US is an important milestone in our journey building a commercial platform for kidney diagnostics. Today, we are pleased to announce that we have received the first purchase order from Roche. This order represents a first step and an initial commercial action toward significantly advancing adoption of ProNephro AKI in the US."
Addressing Unmet Medical Need in AKI Detection
Acute kidney injury represents a common clinical syndrome where early detection is crucial for patient outcomes. BioPorto's NGAL-based tests are designed to address significant unmet medical need in conditions where the company's diagnostics can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.
The company's expertise in antibodies and assay development, combined with its platform for assay development, has enabled the creation of novel diagnostic products focused on actionable biomarkers. These tools are designed to help clinicians make changes in patient management based on more timely and accurate risk assessment.
BioPorto currently markets NGAL tests under applicable registrations including CE mark in several countries worldwide, with the US launch representing a major expansion of its global footprint. The company maintains facilities in Copenhagen, Denmark and Boston, Massachusetts, with shares listed on the Nasdaq Copenhagen stock exchange.
The announcement does not alter BioPorto's previously issued guidance for 2025, indicating that this initial commercialization milestone aligns with the company's established financial projections and strategic timeline.
