D-dimer Assay for Thromboembolism

The assay has been cleared by the U.S. Food and Drug Administration (FDA) for use as an aid to the diagnosis of DVT, venous thromboembolism (VTE) and pulmonary embolism (PE).

With DVT, a blood clot forms in the deep veins of the legs, pelvis, or upper extremities, leading to either partially or completely blocked circulation. Symptoms may vary, but in as many as 50% of patients, few or no symptoms are seen. Early diagnosis and treatment are essential. PE occurs when a clot breaks loose or embolizes and travels to the lungs or pulmonary artery. PE causes more U.S. deaths annually than breast cancer, highway fatalities, or AIDS. VTE is thromboembolism that occurs in the veins.

"The ability to use the D-dimer test as an aid in the diagnosis of VTE, DVT, or PE provides another significant offering to hospital laboratories worldwide,” said Jim Reid-Anderson, chairman, president, and CEO of Dade Behring, which developed the test. "Receiving FDA clearance for the expanded use for this assay is extremely important to Dade Behring because it provides another important tool for physicians to utilize, along with pretest probability assessment, as an aid in the diagnosis of venous thromboembolism (DVT or PE).”





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