BioPorto, an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), recently received marketing clearance by the US Food and Drug Administration (FDA) for ProNephro AKI (NGAL) for risk assessment of moderate-to-severe acute kidney injury (AKI) for pediatric patients. A similar product, The NGAL Test, is also available for testing pediatric and adult populations under CE mark in Europe, Israel, Canada and South Korea.
While the primary indication for BioPorto’s NGAL test is AKI, a new scientific meta-analysis of NGAL based on 25 studies with more than 2,900 patients confirms that urine NGAL (uNGAL) could be a highly accurate biomarker for early urinary tract infection (UTI) detection.
The review, published in Frontiers in Pediatrics by a team at the Cincinnati Children’s, found that uNGAL levels in pediatric populations with UTI symptoms were significantly elevated in patients with culture-confirmed UTIs compared to those without UTIs.
The review highlighted the high sensitivity (96%) and specificity (97%) of uNGAL, indicating a rapid and accurate alternative to current diagnostic methods for UTI – a disease with more than 400 million global cases annually. Similar results were observed in adult studies, indicating the potential for uNGAL as a universal biomarker for UTI diagnosis across age groups.
Dr. Prasad Devarajan, Division of Nephrology and Hypertension and Department of Pediatrics, Cincinnati Children’s, OH (US) and co-author of the study, commented: “NGAL’s potential ability to be used in early diagnosis of UTI is a very important discovery. While the current standard for UTI diagnosis (urine culture) is delayed by 2-3 days, uNGAL can detect UTI within hours, expanding the window of clinical intervention. Early and accurate identification of UTIs is crucial for preventing severe complications such as sepsis, renal scarring, and chronic kidney disease (CKD). The use of uNGAL can facilitate prompt treatment, and hence reduce the risk of these serious illnesses. Furthermore, the high specificity of uNGAL suggests false-positive diagnoses can be avoided, thereby preventing the over-prescription of antibiotics, which is a common issue with current diagnostic methods.”
Peter Mørch Eriksen, CEO of BioPorto commented: “The findings of the review are indeed encouraging for BioPorto. While further prospective studies to validate and confirm the use of uNGAL as a biomarker in UTI are required, they highlight the uniqueness of NGAL as a biomarker and the label expansion potential for our NGAL Test in areas other than AKI. BioPorto’s focus is on the commercial launch of ProNephro AKI (NGAL) in the US and pending US clinical studies for an adult FDA indication of ProNephro AKI (NGAL), but we will consider how results from the review align with the company’s strategy for label expansion of NGAL assays.”
