The U.S. Food and Drug Administration (FDA) has approved the ConcizuTrace™ ELISA Companion Diagnostic (CDx) test, which helps to determine the amount of concizumab-mtci that is circulating in an individual who has taken the product.
Concizumab-mtci is a subcutaneous therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. The product is manufactured by Novo Nordisk and was approved under the brand name Althemo® by the FDA in December of 2024. It is developed using a synthetically produced (recombinant) antibody derived from a single cell clone designed to be equally effective in individuals with hemophilia A and B, irrespective of inhibitor status.
Concizumab-mtci targets an anticoagulant protein known as tissue factor pathway inhibitor (TFPI) and works by blocking and effectively preventing TFPI from performing the anticoagulant function that it naturally carries out in the human body. This type of therapy allows treaters to forgo the need for regular prophylaxis with traditional, intravenously infused factor replacement.
The ConcizuTrace ELISA CDx test was developed as a new option for determining the amount of concizumab-mtci in hemophilia patients. It is an enzyme linked immunosorbent assay (ELISA) intended for the quantitative measurement of concizumab-mtci concentration in human plasma samples from hemophilia A and B patients after four weeks from when treatment began. ELISA is a laboratory technique that is often used to detect specific antibodies, antigens, proteins, and hormones in bodily fluids. These measurements are used to help inform any adjustments that may be made to optimize dosing.
The test is manufactured by Randox Laboratories, who in a recent press release said that this FDA approval follows more than three years of “innovative development and collaboration” with Novo Nordisk. Visit the Randox website to learn more about the test, including additional tools used for blood sample collection and transportation, and the web portal platform used for housing accessing test results.
Source: Randox press release dated June 2, 2025, Select Science, June 3, 2025
