BioPorto: Potential for labelling expansion of NGAL test
BioPorto published interesting news July the 17th. regarding a new meta-analysis of NGAL in UTI (Urinary Tract Infection). The analysis based on 25 studies with more than 2,900 patients confirms that urine NGAL (uNGAL) could be highly accurate biomarker for UTI detection. The review is published by “Frontiers in Pediatrics” an organization specialized in pediatric patient care and child health. 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 urinary tract infection is a very common type of infection in your urinary system with more than 400 million global cases annually.
CEO Peter Mørch Eriksen gave the following comment: “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.”
We host an event with BioPorto August 15th. at 10:30 – sign up here: Bioporto Q2 event
Disclaimer: HC Andersen Capital receives payment from BioPorto for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 11:15 AM 08-08-2024
BioPorto
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BioPorto is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel. It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for adult indication as well as other markets.
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