The US Food and Drug Administration (FDA) cleared STA® - Liatest® D-Di for the exclusion of the diagnosis of deep vein thrombosis (DVT) on data reported from the multi-national, DiET study. Clearance for exclusion of the diagnosis of pulmonary embolism (PE) was received in 2014.
With a negative predictive value (NPV), sensitivity and specificity of 100%, 100% and 55.2% for DVT exclusion and 99.7%, 97.0% and 75.5% for PE exclusion, respectively, STA®-Liatest® D-Di demonstrates best-in-class clinical performance of automated D-Dimer assays for exclusion of DVT and PE within the rigorous requirements of a comprehensive, prospective management study compliant with CLSI H59-A, Quantitative D-Dimer for the exclusion of venous thromboembolic disease, approved guideline, 2011.
Thomas Lawlor, Chief Operating Officer said, “STA® -Liatest® D-Di has been the standard-of-care for quantitative, automated D-Dimer assays in thousands of hospitals, medical centers and private laboratories for more than 15 years with more than 2 million patient results reported worldwide. The combined performance of DVT and PE clinical results for exclusion in the 5-year DiET study demonstrates Stago’s enduring commitment to quality and excellence in patient care.”
D-Dimer results are critical to the diagnostic algorithm for the exclusion of VTE in low and moderate pre-test probability patients and their use is guided by CLSI Document H59-A. To demonstrate reliable clinical performance and compliance with the rigorous requirements of CLSI H59-A, Stago conducted a 5-year, multi-national, prospective management study, including pre-test probability assessment, objective imaging results and 3-month patient follow-up: the DIET study, registered with the US National Institutes of Health (NCT012218050).
More than 2000 outpatients were enrolled in the DiET study with a suspicion of deep vein thrombosis (DVT) or pulmonary embolism (PE) in 16 sites in North America and Europe: United States (10), Canada (1), France (2), Italy (2) and Spain (2). Results exceeded FDA and CLSI performance goals required for Sensitivity and Negative Predictive Value (NPV), the two most relevant criteria for exclusion of DVT and PE in patients with low or moderate pre-test probability.
STA®-Liatest® D-Di also demonstrated best-in-class clinical specificity in the DiET study. Higher specificity indicates fewer false positive D-Dimer results and fewer unnecessary referrals for imaging studies that may increase the cost of patient care, increase length of stay and increase patient exposure to radiation and associated complications of imaging studies.
FDA continues to raise the bar for demonstration of clinical utility and patient safety. STA® - Liatest® D-Di once again leads the way in setting the standard for all D-Dimer assays. STA® - Liatest® D-Di with exclusion clearance for DVT and PE provides reliable, fully automated results from a liquid, ready-to-use testing system with best-in-class efficiency of 15-day on-board stability reagent and results in 8 minutes.