Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and older with hemophilia A or B with inhibitors.

The ConcizuTrace ELISA is intended for quantitative measurement of concizumab-mtci concentration in human 3.2% citrated plasma samples from hemophilia A and B patients after 4 weeks from treatment initiation. This companion diagnostic addresses a critical therapeutic drug monitoring need, as the assay enables clinicians to determine blood concentrations of Alhemo to aid dose adjustments. The de novo pathway approval signifies FDA recognition of this as a novel diagnostic device class with substantial clinical utility.

The diagnostic approval supports optimal dosing strategies for concizumab, a tissue factor pathway inhibitor (TFPI) antagonist that represents a significant therapeutic advance for patients with inhibitor-complicated hemophilia. For patients with hemophilia B, treatment options are especially limited, with the FDA granting Breakthrough Therapy designation to Alhemo based on Phase 2 clinical trial results. The companion diagnostic’s ability to monitor drug levels could prove essential for maximizing efficacy while minimizing bleeding risks in this vulnerable patient population.

“The approval of Alhemo represents a meaningful advancement for people with hemophilia A or B with inhibitors,” noted Anna Windle, senior vice president of Clinical Development at Novo Nordisk. The paired diagnostic-therapeutic approach reflects growing precision medicine trends in rare bleeding disorders, where individualized dosing optimization is crucial for patient outcomes.

This regulatory success positions Randox to capitalize on the companion diagnostics market for specialty hemophilia therapeutics, which faces significant unmet medical needs given the complexity of inhibitor management. The ConcizuTrace ELISA’s commercial potential extends beyond initial approval, as therapeutic drug monitoring requirements may expand with broader clinical experience and potential label extensions for younger pediatric populations.