Novel Assay Determines Medication Received by Hemophilic Patients

Dosing accuracy has long been a challenge in the treatment of hemophilia, especially when it comes to monitoring how much medication a patient has actually received. Now, a breakthrough test designed to measure drug levels in hemophilia patients and support more precise dose adjustments.

ConcizuTrace ELISA (enzyme-linked immunosorbent assay), developed by Randox Laboratories (Crumlin, UK) in close partnership with Novo Nordisk (Bagsværd, Denmark), quantitatively measures concizumab-mtci levels in blood plasma. Specifically, it is intended for use in hemophilia A and B patients four weeks after they begin treatment, helping clinicians decide whether a dosage change is needed in line with the drug’s labeling.

Randox has received approval from the U.S. Food and Drug Administration (FDA) for its De Novo application for ConcizuTrace ELISA, making it the company’s first CDx to receive such an approval. The newly approved diagnostic is part of the broader Randox ConcizuTrace ELISA Service Solution — a comprehensive offering that includes a sample collection kit, the diagnostic test itself, and a web portal for managing patient data and test results. The platform is supported by robust logistical and technical infrastructure designed to streamline sample collection, analysis, and reporting.

With a global testing network now active in the US, Europe, and Japan, Randox ensures a 10-working day turnaround time for results. Partner labs have been selected based on stringent quality and technical standards to meet international testing needs. Over the course of the collaboration, testing laboratories have become active in US, Europe and Japan as the ConcizuTrace ELISA assay is already approved in both regions. This milestone marks a significant advancement in individualized care for hemophilia patients, offering clinicians a reliable way to monitor treatment efficacy.

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