BioPorto Initiates US Study of ProNephro AKI (NGAL) for Adult Acute Kidney Injury Risk Stratification
Key Insights
BioPorto (search) has commenced a US clinical study for ProNephro AKI (NGAL) (search) at Massachusetts General Hospital to determine a cut-off point for AKI (search) risk stratification in adults.
The study aims to enroll patients at up to 12 US sites in 2024 and 2025, with a validation study to follow, supporting an FDA application for adult use by 2026.
ProNephro AKI (NGAL) (search) is already FDA-cleared for pediatric use and detects kidney cell damage earlier than traditional methods, potentially enabling prompt intervention.
BioPorto (search) A/S has announced the enrollment of the first patient in its US clinical study for ProNephro AKI (NGAL) (search)™ at Massachusetts General Hospital. The study aims to establish a cut-off point for risk stratification of moderate to severe Acute Kidney Injury (search) (AKI (search)) in adult patients.
Clinical Significance of Early AKI Detection
Acute Kidney Injury (search) (AKI (search)) is a sudden episode of kidney failure or damage that occurs within hours or days, leading to a build-up of waste products in the blood and disrupting fluid balance. AKI can severely impact other organs, including the brain, heart, and lungs, and is particularly prevalent in intensive care units. Early detection of AKI is crucial as it allows for timely interventions that can save lives.
ProNephro AKI (NGAL): A Novel Biomarker
BioPorto (search)'s ProNephro AKI (NGAL) (search) assay offers a potential solution for early AKI (search) detection. NGAL (search) (Neutrophil gelatinase-associated lipocalin) is a direct, real-time marker of kidney cell damage, potentially identifying AKI days earlier than traditional serum creatinine (SCr) tests. The assay is already FDA-cleared for patients aged 3 months to 21 years.
Study Design and Objectives
The current cut-off study is the first of two planned studies to support US FDA clearance of ProNephro AKI (NGAL) (search) for adult patients. The study aims to enroll patients at up to 12 US sites throughout 2024 and 2025. Following the establishment of the cut-off point, a validation study will commence, enabling BioPorto (search) to submit its FDA application for adult usage of ProNephro AKI (NGAL) by 2026.
Market Opportunity
Peter Mørch Eriksen, Group CEO of BioPorto (search), stated, "Accelerating the clinical process and obtaining FDA clearance for the adult test will be a very important milestone in providing clinicians this new important tool for assessing risk for clinically significant AKI (search), and opening up a global market valued at more than USD 3 billion annually."
About BioPorto
BioPorto (search) is an in vitro diagnostics company focused on developing actionable biomarkers to improve patient outcomes. Their flagship products, based on the NGAL (search) biomarker, are designed to aid in the risk assessment and diagnosis of Acute Kidney Injury (search).