Antithrombin Blood Test from Siemens Healthineers Now FDA Cleared as a Companion Diagnostic for Qfitlia, a Sanofi Hemophilia Therapy

• The assay now can measure antithrombin (AT) activity levels for people treated with Qfitlia
• Measuring AT activity levels helps people receive the appropriate dose, initially and over time
• The test is used before and during treatment with Qfitlia as part of the AT-based dosing regimen

Siemens Healthineers announced today 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.¹ 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.

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Siemens Healthineers announced today 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.

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.

¹ 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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Siemens Healthineers pioneers breakthroughs in healthcare. For everyone. Everywhere. Sustainably. The company is a global provider of healthcare equipment, solutions and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. As a leading medical technology company, Siemens Healthineers is committed to improving access to healthcare for underserved communities worldwide and is striving to overcome the most threatening diseases. The company is principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2024, which ended on September 30, 2024, Siemens Healthineers had approximately 72,000 employees worldwide and generated revenue of around €22.4 billion. Further information is available at www.siemens-healthineers.com.

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"When we collaborate to innovate, we can achieve impactful advancements that can change lives and improve patient outcomes," said Bob Stowers, head of Specialty Lab Solutions, Diagnostics, Siemens Healthineers