Siemens Healthineers’ Antithrombin Blood Test Gains FDA Clearance as Qfitlia Companion Diagnostic

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. Hemophilia is a lifelong genetic bleeding disorder that significantly affects the day-to-day lives of people living with the disease, creating potentially life-threatening risks from otherwise normal situations experienced by those without hemophilia. The body’s inability to clot blood effectively can prolong bleeding after injuries, result in excessive bruising and joint pain, and increase risks during surgery or other medical procedures.

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.

“Every healthcare industry player has a meaningful role in driving patient care forward. When we collaborate to innovate, we can achieve impactful advancements that can change lives and improve patient outcomes. Diagnostics tests such as the Siemens Healthineers Innovance Antithrombin assay provide greater clinical utility when test results directly aid patients' next step in their treatment,” said Bob Stowers, head of Specialty Lab Solutions, Diagnostics, Siemens Healthineers.

The Innovance Antithrombin assay from Siemens Healthineers is used broadly to detect genetic or acquired AT deficiencies.

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.

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