Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitors
Hemophilia A and B are inherited bleeding disorders defined by reduced factor activity. Testing for inhibitor status is clinically relevant and may guide therapy selection.
Biomarkers used in this indication
Each approval combines this indication with specific biomarker criteria and a therapy. Select a therapy from the tables below to open its FDA-defined testing pathway.
Defined explicitly for Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitors in FDA labeling.
Defined at the solid tumor level and applicable to Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitors and other solid tumor cancers.
No tumor-agnostic biomarker approvals are currently mapped for this indication.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitors. Select a therapy to view the specific approval and eligible tests.
Concizumab (Tissue factor pathway inhibitor antagonist)
Antithrombin III (Functionally active Antithrombin III)