NEW YORK – Nordic Bioscience on Monday said it has received a letter of support from the US Food and Drug Administration for its CPa9-HNE assay, which tests for a biomarker of inflammatory bowel disease (IBD) activity.
Herlev, Denmark-based Nordic Bioscience said CPa9-HNE is a biomarker that measures a fragment of calprotectin, S100a9, which is produced by human neutrophil elastase. With the FDA's letter of support, Nordic Bioscience has more confidence that the CPa9-HNE assay can be potentially used to select IBD patients for clinical trials and monitor disease activity and treatment response.
"This marker has the potential to be applied as a patient enriching tool for clinical trials in the future, by identifying patients more likely to have moderate or severe endoscopic disease activity," Joachim Høg Mortensen, the company's scientific director of gastrointestinal diseases, said in a statement.
Nordic Bioscience's assay detects the biomarker in the serum and plasma of patients with IBD and quantifies activated neutrophils, which are immune cells that contribute to the disease. CPa9-HNE is currently measured using a handheld enzyme-linked immunosorbent assay (ELISA), but Nordic Bioscience is developing an automated platform.
Nordic Bioscience has developed more than 125 ELISA biomarker tests to quantify extracellular matrix fragments, including CTX-I for measuring bone resorption and PRO-C3 for measuring fibrotic activity in patients with solid tumors. The firm has transferred these two biomarkers to Roche's Cobas molecular diagnostic testing platform.