FDA Approves ConcizuTrace™ ELISA Companion Diagnostic for 2024 Concizumab Therapy in Hemophilia
The National Bleeding Disorders Foundation (NBDF) shared a post on X:
”The FDA has approved the ConcizuTrace™ ELISA Companion Diagnostic test to measure concizumab-mtci levels in hemophilia A and B patients.’
To learn more about this advancement, follow the link.
The U.S. Food and Drug Administration (FDA) has approved the ConcizuTrace™ ELISA Companion Diagnostic, a test designed to measure plasma levels of concizumab-mtci in patients with hemophilia A or B.
Concizumab-mtci is a subcutaneous therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (≥12 years) with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.
The approval of this companion diagnostic marks a significant step in personalizing treatment, enabling clinicians to monitor drug exposure and potentially optimize therapeutic outcomes.
Never miss the important in the World of Hemophilia, read Hemostasis Today.
-
Feb 24, 2026, 16:18Salmaan Dalvi: Mapping Rare Diseases Across East and Central Africa
-
Feb 24, 2026, 16:16Wolfgang Miesbach: Game‑Changing Data on Intensive FVIII Replacement in Haemophilia A with Hypertrophic Synovium
-
Feb 24, 2026, 16:01Is It Safe to Briefly Stop Anticoagulation After VTE? – RPTH Journal
-
Feb 24, 2026, 15:58Anastasia Conti: Honored to Receive the Roche Foundation Grant for Independent Research in Onco-Hematology
-
Feb 24, 2026, 15:55Courtney Lawrence: Targeted Donor Screening Reduces Transfusion-Transmitted Babesia Cases
-
Feb 24, 2026, 15:30Aswin K Mohan: Practical Tips for Preparing Before, During, and After Blood Donation
-
Feb 24, 2026, 15:24Stéphanie Forté: The Hidden Burden of Stroke in Adults Living with Sickle Cell Disease
-
Feb 24, 2026, 15:13Tagreed Alkaltham: Equity in Emergency Care Through a Blood Bank Lens
-
Feb 24, 2026, 14:57Joseph Raffaele: Can Improving Mitochondrial Quality in Immune Cells Alter Immune Aging Markers?