Siemens Healthineers 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).

D-dimer testing helps assess patients with conditions and/or 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 the next steps for their patients’ care. The Innovance D-Dimer 2.0 assay from Siemens Healthineers is intended for DVT and PE exclusion in conjunction with a clinical pretest probability (PTP) assessment model in outpatients suspected of DVT or PE. It also is used to aid in the diagnosis and monitoring of hypercoagulable conditions, including disseminated intravascular coagulation (DIC) – a serious condition that may occur in patients suffering, for example, from sepsis, malignancy, or toxic snake bites.

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 optimal 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. Analytical robustness and high specificity can help clinicians safely rule out patients from unnecessary imaging and follow-up procedures.

The assay is now available across many markets, with expanded availability expected in October. 

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