Siemens Healthineers launches INNOVANCE D-Dimer 2.0 globally to support VTE assessment
D-dimer testing measures fragments produced when blood clots break down and can help assess patients with increased clotting activity.
USA—Siemens Healthineers has launched its INNOVANCE D-Dimer 2.0 assay globally to support the assessment of suspected venous thromboembolism (VTE), following CE marking and FDA 510(k) clearance.
The blood test is designed to help clinicians assess patients with suspected deep vein thrombosis (DVT) and pulmonary embolism (PE), two conditions associated with potentially serious blood clots.
Supporting faster clot assessment
Siemens Healthineers said the assay is intended to help laboratories provide results within time-sensitive clinical workflows.
D-dimer testing measures fragments produced when blood clots break down and can help assess patients with increased clotting activity.
VTE risk can increase in several clinical settings, including periods of immobilization, cancer treatment, pregnancy, and the postpartum period.
In patients suspected of having DVT or PE, D-dimer results are generally interpreted alongside a clinical pretest probability (PTP) assessment to help determine whether further diagnostic investigation is warranted.
“Minutes matter when clinicians are evaluating a patient for a serious blood clot,” said Martin Fuhrer, head of Specialty Laboratory Solutions for Diagnostics at Siemens Healthineers.
“Our new D-dimer assay is designed to help laboratories deliver timely, high-quality results that underpin quicker, confident clinical decisions.”
The company also said the INNOVANCE D-Dimer 2.0 assay can support the diagnosis and monitoring of hypercoagulable conditions, including disseminated intravascular coagulation (DIC).
DIC can occur in association with conditions such as sepsis, malignancy and some cases of toxic snakebite.
Focus on laboratory workflow
The launch comes as clinical laboratories manage rising testing volumes while responding to demand for urgent, or STAT, testing.
Siemens Healthineers said the assay uses ready-to-use reagents and controls and is designed to provide a short time to results.
The company also points to workflow features intended to support emergency department triage and timely clinical decision-making.
Its analytical performance is designed to provide high specificity, which Siemens Healthineers said may help clinicians exclude some patients from unnecessary imaging and subsequent procedures when used within appropriate diagnostic pathways.
The assay forms part of Siemens Healthineers’ broader coagulation testing portfolio for thrombotic conditions and other hemostasis disorders.
It is intended for use on compatible Siemens Healthineers hemostasis systems, extending the company’s offering for laboratories that require automated coagulation testing across different clinical settings.
Regulatory and market availability
The INNOVANCE D-Dimer 2.0 assay is now available in several markets, according to Siemens Healthineers, with availability expected to expand in October.
The product’s launch adds another assay to the diagnostics industry’s efforts to support standardized, automated testing for conditions that require rapid clinical assessment.
For laboratories, ready-to-use reagents and integration with existing hemostasis systems may also affect workflow and testing capacity as demand for coagulation diagnostics grows.
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