Antithrombin blood test from Siemens Healthineers now FDA cleared as a companion diagnostic for Qfitlia, a Sanofi hemophilia therapy
Siemens Healthineers announced its Innovance Antithrombin assay has achieved FDA clearance for a new claim allowing it to be used as a companion diagnostic test for people receiving treatment with Qfitlia (fitusiran), a Sanofi hemophilia therapy.
This expanded claim is intended for use in the United States. Claims relevant to use cases in other markets can be found on the Siemens Healthineers website.
Qfitila will support people living with hemophilia A or B, with or without inhibitors, by helping to rebalance one of the body’s critical clotting mechanisms to prevent bleeding. The Innovance Antithrombin blood test from Siemens Healthineers will aid in monitoring patients’ AT activity to support Qfitlia dosing in adult and pediatric patients aged 12 years and older. It is the only assay cleared for this indication.
The Innovance Antithrombin assay from Siemens Healthineers is used broadly to detect genetic or acquired AT deficiencies.
