Randox Laboratories has announced that the U.S. Food and Drug Administration (FDA) has approved its De Novo application for the company’s first Companion Diagnostic (CDx), marking a significant milestone after over three years of development in collaboration with Novo Nordisk. The newly approved diagnostic, the Randox ConcizuTrace™ ELISA (enzyme-linked immunosorbent assay), provides a novel and precise method for monitoring treatment in patients with hemophilia A and B.
The ConcizuTrace™ ELISA is specifically designed for the quantitative measurement of concizumab-mtci concentrations in human 3.2% citrated plasma samples, taken from patients four weeks after starting therapy. This measurement plays a critical role in guiding dose adjustments of concizumab, in line with the drug’s prescribing information, ensuring more accurate and individualized treatment.
This FDA approval underscores Randox’s commitment to advancing personalized medicine and highlights the importance of accurate therapeutic monitoring in hemophilia care. The diagnostic enhances clinical decision-making by offering a validated and standardized tool to assess drug exposure in patients, improving both safety and efficacy.
The ConcizuTrace™ ELISA forms the core of the Randox ConcizuTrace™ ELISA Service Solution, a comprehensive global offering. The solution includes the ConcizuTrace™ Sample Collection Kit, which contains all necessary materials for blood sample collection and transportation, the Companion Diagnostic ELISA for laboratory analysis, and a secure web portal for managing test results and accessing logistical and technical support.
With a robust network of quality-accredited laboratories and logistics partners, Randox ensures a 10-working-day turnaround for test results. Testing laboratories have been strategically established in the U.S., Europe, and Japan, where the assay has already received regulatory approvals, allowing the service to support global clinical needs efficiently.
Through this launch, Randox strengthens its position as a leader in diagnostic innovation, supporting clinicians and patients worldwide with cutting-edge tools for precision medicine in hemophilia management.