BioPorto Initiates Patient Enrollment for Adult AKI Study

BioPorto A/S has initiated the enrollment of the first patient in a significant clinical study aimed at validating the use of its ProNephro AKI® test for the detection of acute kidney injury (AKI) in adult patients. The study, titled the ProNephro AKI U.S. Adult Urine NGAL Validation Study, is a crucial step in BioPorto’s strategy to expand the use of its NGAL-based diagnostic tool to the adult population in the United States.

CEO Carsten Buhl commented, "Today’s first patient enrollment marks another major milestone in BioPorto’s strategy to expand ProNephro AKI into the U.S. adult market. Following the successful completion of the AKI cut-off study, we are now advancing into the validation phase with a study designed to enroll approximately 900 patients across leading U.S. hospitals."

The study is expected to validate the clinical performance of ProNephro AKI (NGAL) for risk assessment of moderate to severe AKI in adult patients admitted to the Intensive Care Unit (ICU). The ProNephro AKI U.S. Adult Urine NGAL Validation Study will create a broad and representative clinical dataset, which is essential for supporting the expansion of ProNephro AKI (NGAL) to adult patients.

BioPorto will continue to work with ProPharma, the same clinical research organization that assisted in the preceding AKI cut-off study. ProPharma will be responsible for enrolling patients and managing the study across multiple U.S. clinical sites. The study is expected to enroll approximately 900 patients, providing a comprehensive dataset to support the potential adult indication in the United States.

ProNephro AKI (NGAL) is currently cleared by the U.S. Food and Drug Administration (FDA) for patients aged 3 months through 21 years. The ProNephro AKI U.S. Adult Urine NGAL Validation Study is intended to support BioPorto’s clinical and regulatory pathway toward a potential adult indication in the United States. The study will help BioPorto generate the necessary clinical evidence to support the expansion of its diagnostic tool to a broader patient demographic.

The first patient in the ProNephro AKI U.S. Adult Urine NGAL Validation Study has been enrolled at Massachusetts General Hospital. The study is expected to take place across multiple U.S. clinical sites, ensuring a diverse and representative sample of patients. This will help BioPorto gather the data needed to validate the clinical performance of ProNephro AKI (NGAL) for the adult population.

BioPorto’s flagship products are based on the NGAL biomarker and are designed to aid in the risk assessment and diagnosis of AKI. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies.

The ProNephro AKI U.S. Adult Urine NGAL Validation Study is a critical step in BioPorto’s efforts to expand its diagnostic tool to the adult population in the United States. The study’s success will be essential in providing the necessary clinical evidence to support the potential adult indication, ultimately improving patient outcomes and the overall quality of care.