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鈩 (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鈥檚 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.听
Qfitila will support people living with hemophilia A or B, with or without inhibitors, by helping to rebalance one of the body鈥檚 critical clotting mechanisms to prevent bleeding. The Innovance Antithrombin blood test from Siemens Healthineers will aid in monitoring patients鈥 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. 听
鈥淓very 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'鈥痭ext step in their treatment,鈥 said Bob Stowers, head of Specialty Lab Solutions, Diagnostics, Siemens Healthineers.听
The Innovance Antithrombin assay from Siemens Healthineers is used broadly to detect genetic or acquired AT deficiencies.听
Media contact
Kimberly Nissen听
Phone: 610-241-2129
Email: Kimberly.Nissen@siemens-healthineers.com 听
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 鈧22.4 billion. Further information is available at .听
