Siemens Healthineers has introduced its Innovance D-Dimer 2.0 assay globally following CE mark certification and 510(k) clearance from the US Food and Drug Administration.
The blood test assists clinicians in evaluating patients suspected of venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT).
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Healthcare providers use the assay alongside a clinical pretest probability assessment model to rule out PE and DVT in outpatients.
The test also facilitates in diagnosing and monitoring hypercoagulable disorders such as disseminated intravascular coagulation. This critical condition can arise in individuals affected by malignancy, sepsis, or toxic snake bites.
Siemens Healthineers Diagnostics Specialty Laboratory Solutions head Martin Fuhrer said: “Minutes matter when clinicians are evaluating a patient for a serious blood clot. Our new D-dimer assay is designed to help laboratories deliver timely, high-quality results that underpin quicker, confident clinical decisions.”
The assay incorporates ready-to-use reagents and controls designed to deliver fast results.
These features assist clinical laboratories with emergency department triage and urgent order processing while managing high testing volumes and staffing constraints.
Furthermore, the test’s analytical specificity helps clinicians safely rule out conditions without the need for unnecessary imaging and follow-up examinations.
The Innovance D-Dimer 2.0 assay forms part of the Siemens Healthineers thrombotic disorder range and operates on the company’s haemostasis platforms.
The product is currently available across several markets, with expanded commercial availability scheduled for October.
In September 2025, Siemens Healthineers and Cook Medical entered into an MRI partnership, aiming to create the first purpose-built interventional suite using the scanning technology.
The companies’ completed, ionic radiation-free interventional MRI (iMRI) suites will streamline functions including real-time imaging, thereby making teamwork seamless in areas including interventional oncology and structural heart procedures.
