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 (K253985). The blood test helps clinicians assess patients with suspected venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).

The assay 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 is also used to aid in the diagnosis and monitoring of hypercoagulable conditions, including disseminated intravascular coagulation (DIC), a serious condition that may occur in patients with, for example, sepsis, malignancy or toxic snake bites. The company notes that the DIC claim is not applicable in the US.

Siemens Healthineers cites the International Society on Thrombosis and Haemostasis in stating that blood clots affect approximately 10 million people each year worldwide. Clots are especially dangerous when they break loose and travel to the heart, lungs and brain, preventing oxygen from reaching vital organs. D-Dimer testing helps assess patients with conditions or complications that increase clotting activity. Siemens Healthineers notes there is a higher risk of VTE during or shortly after immobilisation, during cancer treatment, and during pregnancy or postpartum.

Workflow features

Clinical laboratories are often asked to process urgent STAT orders while managing rising test volumes and staffing constraints. According to Siemens Healthineers, the assay helps laboratories achieve operational efficiency through ready-to-use reagents and controls and a short time to results, while a high level of clinical safety supports confident patient management. Workflow-oriented features are intended to enable fast emergency department triage and timely treatment decisions. The company adds that analytical robustness and high specificity can help clinicians safely rule out patients from unnecessary imaging and follow-up procedures.

“Minutes matter when clinicians are evaluating a patient for a serious blood clot,” said Martin Fuhrer, head of Specialty Laboratory Solutions for Diagnostics, Siemens Healthineers. “Our new D-Dimer assay is designed to help laboratories deliver timely, high-quality results that underpin quicker, confident clinical decisions.”

Availability

The assay forms part of the company’s coagulation portfolio for thrombotic conditions and disorders and is available for a variety of haemostasis systems, including the CN-3000 and CN-6000 systems from Siemens Healthineers. It is now available across many markets. Siemens Healthineers notes that product availability varies by country, and that the products, features and applications mentioned are not commercially available in all countries and are subject to local regulations.

Siemens Healthineers AG is a global provider of healthcare equipment, solutions and services, active in more than 180 countries, principally in imaging, diagnostics, cancer care and minimally invasive therapies. In fiscal 2025, which ended on 30 September 2025, it had approximately 74,000 employees worldwide and generated revenue of around €23.4 billion.

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