FDA approves Randox ConcizuTrace ELISA CDx
July 2025—The Food and Drug Administration has approved the de novo application for Randox Laboratories’ first companion diagnostic, the Randox ConcizuTrace ELISA. The test, developed in collaboration with Novo Nordisk, is intended for the quantitative measurement of concizumab-mtci concentration in human 3.2 percent citrated plasma samples from patients with hemophilia A and B four weeks after the initiation of treatment. The measurement of the concentration is used for dose adjustment decision in accordance with the drug label.