Marcy l'Etoile, France - May 6th, 2004. bioMérieux announces that following prospective management studies on its VIDAS D-Dimer test resulting in FDA approval and CE marking, the VIDAS D-Dimer New test has been renamed VIDAS D-Dimer Exclusion™. This name change will more accurately reflect the new intended use of the VIDAS D-Dimer Exclusion test, and also reinforce awareness of the significant role D-dimers can play in exclusion strategies for thromboembolic disease.
Indeed, the measurement of D-dimers can be used as a non-invasive aid to exclude outpatients with suspected deep vein thrombosis (DVT) or pulmonary embolism (PE), thereby avoiding further invasive and more costly examinations. However, the sensitivity of a D-Dimer test is of key importance, since even a slight decrease in sensitivity can have serious consequences for the patient, who may subsequently not receive the appropriate treatment.
bioMérieux’s VIDAS D-Dimer test has been validated by extensive studies published over the past ten years, involving over 10,000 patients worldwide. The results of these studies have contributed to the evolution of diagnostic practices within hospitals and the test performance in terms of sensitivity has positioned VIDAS D-Dimer as the reference test for the exclusion of venous thromboembolism (VTE).
Moreover, VIDAS D-Dimer Exclusion is now the first and only D-dimer test on the market to be supported by prospective management studies. In these studies, physicians adapt their decision to stop further investigations on the basis of the clinical pretest probability (PTP) score and a D-dimer result lower than the clinical decision cut-off (< 500 ng/ml). The most recent study, led by Dr A. Perrier and colleagues and published in The American Journal of Medicine (2004; 116:291-29), involved 965 patients with suspected pulmonary embolism. The level of sensitivity obtained with VIDAS D-Dimer Exclusion during this study was 100%.
These management studies have enabled bioMérieux to obtain FDA approval for the “exclusion of DVT … and aid in the diagnosis of PE”. The CE Mark states that “VIDAS D-Dimer Exclusion is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude DVT and PE in outpatients suspected of VTE”. These statements make VIDAS D-Dimer Exclusion the only test available on the market that is validated for patients with a Low or Medium pretest probability score to safely exclude the risk of DVT or PE.