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BioPorto Successfully Completes Preliminary Analysis of U.S. Adult NGAL Cutoff Study; Pre-Submission expected by End of Q1 2026
March 18, 2026Announcement no. 03 BioPorto Successfully Completes Preliminary Analysis of U.S. Adult NGAL Cutoff Study; Pre-Submission expected by End of Q1 2026 COPENHAGEN, DENMARK, March 18, 2026 – BioPorto A/S (“BioPorto” or “Company”) (CPH: BIOPOR) today announced positive clinical readout update of the preliminary analysis of its U.S. adult NGAL Cutoff Study, designed to evaluate the clinical performance of NGAL in assessing risk of acute kidney injury (AKI). The Company intends to submit i
About this update from Bioporto A/s
[{"type":"image","alt":"BioPorto A/S","displaySize":"","headline":null,"caption":"BioPorto A/S","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":55,"url":"https://media.zenfs.com/en/globenewswire.com/b7c79bb76fefe5d65277db64dd9691c8"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/XFhYiV2fxrmNbtDA3N3v_A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTc3O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/b7c79bb76fefe5d65277db64dd9691c8","width":300,"height":55}},"lazy":false},{"type":"text","content":"March 18, 2026Announcement no. 03","length":34,"tagName":"p"},{"type":"text","content":"BioPorto Successfully Completes Preliminary Analysis of U.S. Adult NGAL Cutoff Study; Pre-Submission expected by End of Q1 2026 ","length":127,"tagName":"p"},{"type":"text","content":"COPENHAGEN, DENMARK, March 18, 2026 – BioPorto A/S (“BioPorto” or “Company”) (CPH: BIOPOR) today announced positive clinical readout update of the preliminary analysis of its U.S. adult NGAL Cutoff Study, designed to evaluate the clinical performance of NGAL in assessing risk of acute kidney injury (AKI). The Company intends to submit its FDA Pre-submission package by the end of March 2026, to ensure robustness in its subsequent Validation Study.","length":450,"tagName":"p"},{"type":"text","content":"Patient enrollment was completed in October 2025, and database lock was finalized in March 2026. The preliminary analysis of the adult study has shown positive results supporting the study’s primary endpoint, consistent with the findings from the Company’s cutoff and validation study conducted in the pediatric segment, which subsequently led to FDA clearance at the end of 2023 for the pediatric indication. This is providing a strong foundation for BioPorto’s regulatory strategy going forward.","length":497,"tagName":"p"},{"type":"text","content":"BioPorto’s Senior Medical Director, Dr. Prasad Devarajan, commented, “We are encouraged with the results from our interim analysis for the clinical performance of the BioPorto assay. The analysis reinforces our confidence that, upon completion of the study, the results provide strong support for the value of NGAL as a biomarker for identifying the risk of AKI in critically ill adults.”","length":388,"tagName":"p"},{"type":"text","content":"The planned Pre-submission will seek FDA’s feedback on the regulatory pathway as ...