ProNephro AKI (NGAL) stands out as the first AKI biomarker test to secure FDA clearance for pediatric use, covering children from 3 months to 21 years old in the United States. Leveraging this regulatory milestone, BioPorto and Roche Diagnostics are broadening their global distribution agreement to encompass the cobas c 503 analyzer, in addition to the existing cobas c 501 and c 502 analyzers.

Peter Mørch Eriksen, CEO of BioPorto, expressed his satisfaction with the extended collaboration, emphasizing Roche Diagnostics' dominant position in the diagnostic realm. He highlighted the strategic significance of this move, aligning with BioPorto's ambition to widen the reach of its NGAL test. The partnership aims to address a crucial healthcare need by facilitating risk assessment and early diagnosis of acute kidney injury, thereby enhancing patient outcomes.

Eriksen further articulated that this expansion marks a pivotal step in executing BioPorto's instrument expansion strategy and prepares the ground for the commercialization of the NGAL test on the cobas c 503 analyzer. He affirmed the joint commitment of BioPorto and Roche Diagnostics towards advancing diagnostic capabilities and improving patient care.

The announcement assures stakeholders that the expansion of collaboration does not alter BioPorto's financial guidance for 2023, as previously communicated in the November 1, 2023 Interim Report.

This collaboration expansion underscores the shared commitment of Roche Diagnostics and BioPorto to advance diagnostic technologies, ushering in a new era of precision medicine and improved patient outcomes in the field of acute kidney injury diagnostics.