The blood test supports outpatient exclusion of deep vein thrombosis and pulmonary embolism and is designed for rapid laboratory STAT testing.
Siemens Healthineers announced the global launch of its Innovance D-Dimer 2.0 assay, which has received US Food and Drug Administration 510(k) clearance and CE mark status. The diagnostic blood test is designed to assist clinicians in evaluating patients with suspected venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism.
Blood clots affect approximately 10 million people worldwide each year and present significant clinical risks when they obstruct normal circulation or break loose to reach the heart, lungs, and brain. Rapid laboratory intervention is critical during these time-sensitive events to support optimal patient outcomes.
“Minutes matter when clinicians are evaluating a patient for a serious blood clot,” says Martin Fuhrer, head of specialty laboratory solutions for diagnostics, Siemens Healthineers, in a release. “Our new D-dimer assay is designed to help laboratories deliver timely, high-quality results that underpin quicker, confident clinical decisions.”
Clinical Applications and Clot Exclusion
D-dimer testing helps clinicians assess individuals presenting with conditions or clinical factors that increase clotting activity, such as periods of immobilization, active cancer treatments, and pregnancy or the postpartum period.
The Innovance D-Dimer 2.0 assay is indicated for the exclusion of deep vein thrombosis and pulmonary embolism in conjunction with a clinical pretest probability assessment model in outpatients suspected of these conditions. Outside the US, the assay is also indicated to aid in the diagnosis and monitoring of hypercoagulable disorders, including disseminated intravascular coagulation, a severe condition linked to sepsis, malignancy, and toxic snake bites.
Optimizing Laboratory Workflows
Hospital and reference laboratories routinely face the challenge of managing emergent STAT orders alongside rising overall test volumes and staffing limitations. The assay is designed to improve operational efficiency with ready-to-use reagents and controls, combined with a short turnaround time to support rapid emergency department triage and treatment pathways.
According to the company, analytical robustness and high specificity help clinicians safely rule out thrombotic events and avoid unnecessary imaging studies and secondary procedures.
The Innovance D-Dimer 2.0 assay runs across various hemostasis platforms, including the CN-3000 and CN-6000 systems. The assay is currently accessible in multiple global markets, with expanded commercial availability anticipated in October.
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