BioPorto A/S, an in vitro diagnostics company focused on empowering the early detection of acute kidney injury (AKI), announced the enrollment of the first patient in its US clinical study for ProNephro AKI (NGAL) with the goal of determining a cut-off point for risk stratification of moderate to severe of AKI in adult patients.
BioPorto's ProNephro AKI (NGAL), currently cleared by the US Food and Drug Administration (FDA) for those 3 months through 21 years of age, has been widely recognized for its groundbreaking potential in refining AKI diagnosis.
NGAL is a direct real-time marker of kidney cell damage and can potentially detect AKI days earlier than previously possible. Early detection of AKI may enable prompt intervention to save lives. BioPorto’s proprietary assay is a kidney injury marker versus the traditionally used serum creatinine (SCr) functional test.
The cut-off study is the first of two studies which will form a substantial part of the submission for US clearance of ProNephro AKI (NGAL) in adult patients.
Peter Mørch Eriksen, group CEO of BioPorto, commented: “With strong interest from participating clinics and hospitals, forceful dedication from our team and leveraging our experience from the paediatric clearance process successfully concluded in 2023, we have progressed from a draft protocol to now enrolling the first patients at Massachusetts General Hospital, MA (US) in a very short time. I am very encouraged by the momentum we have kept, which has allowed us to speed up and commence enrollment ahead of our original plans. 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, and opening up a global market valued at more than USD 3 billion annually.”
The cut-off study seeks to enroll patients at up to 12 US sites in 2024 and 2025. After having established the cut-off, BioPorto expects to commence enrollment for the second study, the validation study, enabling the company to submit its FDA application for adult usage of ProNephro AKI (NGAL) by 2026.
Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units.
BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management.
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