Siemens Healthineers Launches INNOVANCE D-Dimer 2.0 Assay for Blood-Clotting Assessment
Siemens Healthineers has announced the global launch of its INNOVANCE D-Dimer 2.0 assay, which is CE-marked and has received FDA 510(k) clearance. The blood test helps clinicians assess patients with suspected venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Blood clots affect approximately 10 million people each year worldwide and can become dangerous when they block normal blood flow, particularly when they break loose and travel to the heart, lungs, and brain.
D-dimer testing helps assess patients with conditions and complications that increase clotting activity. People face a higher risk of VTE during or shortly after immobilization, during cancer treatment, and during pregnancy or postpartum. During time-sensitive, potentially life-threatening situations, exclusion of DVT and PE helps clinicians confidently determine next steps for patient care. The INNOVANCE D-Dimer 2.0 assay is intended for DVT and PE exclusion in conjunction with a clinical pretest probability assessment model in outpatients suspected of DVT or PE, and it is also used to aid in the diagnosis and monitoring of hypercoagulable conditions including disseminated intravascular coagulation.
Clinical laboratories are often asked to process urgent STAT orders while managing increasing test volumes and staffing constraints. The INNOVANCE D-Dimer 2.0 assay helps laboratories achieve operational efficiency through ready-to-use reagents and controls and short time to results, while a high level of clinical safety supports confident patient management. Workflow-oriented features enable fast emergency department triage and timely treatment decisions, and analytical robustness and high specificity can help clinicians safely rule out patients from unnecessary imaging and follow-up procedures.
The INNOVANCE D-Dimer 2.0 assay is part of Siemens Healthineers’ comprehensive coagulation portfolio for thrombotic conditions and disorders, available for a variety of hemostasis systems including the CN-3000/6000 Systems from Siemens Healthineers. The assay is now available across many markets, with expanded availability expected in October.
Martin Fuhrer, Head of Specialty Laboratory Solutions for Diagnostics at Siemens Healthineers, stated that minutes matter when clinicians are evaluating a patient for a serious blood clot. Fuhrer noted that the new D-dimer assay is designed to help laboratories deliver timely, high-quality results that underpin quicker, confident clinical decisions.
