June 4, 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 after four weeks from the initiation of treatment. The measurement of the concentration is used for dose adjustment decision in accordance with the drug label.
The ConcizuTrace ELISA forms a part of the Global Randox ConcizuTrace ELISA Service Solution, which includes the ConcizuTrace ELISA sample collection kit, ConcizuTrace ELISA CDx, and ConcizuTrace ELISA web portal. The service solution aims to ensure that prescribers and patients receive their results within a turnaround time of 10 working days.