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.
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