HERLEV, Denmark , Nov. 11, 2024 /PRNewswire/ -- Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S.
Food and Drug Administration (FDA). For the past thirty years, Nordic Bioscience has continuously advanced its ProteinFingerprint Biomarker TechnologyTM, driven by its scientific breakthroughs published in high-impact journals, ongoing enhancements to its high-precision automated instruments [1] , and consistent regulatory approvals from official authorities. "This trifecta of scientific excellence, high-quality biomarkers, and regulatory support sets us apart from the competition" commented Morten A.
Karsdal, CEO of Nordic Bioscience . " The CPa9-HNE Letter of Support is not only another landmark achievement signifying our success story, but also something that our hard-working teams can be very proud of." The CPa9-HNE biomarker measures a fragment of calprotectin S100a9, produced by human neutrophil elastase.
It is detected in the serum and plasma of individuals with inflammatory bowel disease (IBD) and quantifies activated neutrophils, offering a non-invasive indicator of disease activity. In IBD trials, a frequent drug evaluation target is treating patients with moderate to severe ulcerative colitis or Crohn's disease. Neutrophils are important immune cells contributing to IBD, and CPa9-HNE can improve disease activity monitoring.
" The Letter of Supports underlines what we have sought .