Marcy l'Etoile, France - July 23rd, 2004. bioMérieux announces that its D-dimer assay, VIDAS D-Dimer Exclusion, is now cleared by the U.S. Food and Drug Administration (FDA) to exclude both pulmonary embolism (PE) and deep vein thrombosis (DVT) as a diagnosis in outpatients. VIDAS D-Dimer Exclusion is the first and only D-dimer assay to be cleared for exclusion of both conditions -- with no further testing -- when used in conjunction with a pre-test probability (PTP) assessment, in low-to-moderate probability outpatients.
This clearance means that patients who present to the Emergency Department with suspected PE or DVT may no longer be subjected to invasive and costly imaging examinations for a negative diagnosis.
PE and DVT, collectively referred to as venous thromboembolism (VTE), affects up to 3 million patients annually and kills up to 200,000 of them, more than breast cancer and HIV combined. However, up to 75% of patients with suspected VTE do not actually have the disease. A negative D-dimer assay result, provided by VIDAS D-Dimer Exclusion, enables clinicians to exclude a diagnosis of DVT and PE in less than an hour with no additional testing.(1)
It is very important to note that not all D-dimer assays are the same. The clinical sensitivity of the assay is of key importance, since even a slight decrease in sensitivity can yield a diagnostic result that can have serious consequences for the patient, who may subsequently not receive appropriate treatment. bioMerieux's VIDAS D-Dimer Exclusion, a rapid, automated ELISA, has a negative predictive value (NPV) of greater that 99%.(*) It has been validated by extensive studies, which include over 11,000 patients worldwide. Results of these studies have contributed to the evolution of diagnostic practices within hospitals where the use of imaging studies is reserved for high pre-test probability patients. Patients in the low-to-moderate probability group who have a negative VIDAS D-Dimer Exclusion result avoid such expensive and potentially risky procedures.
VIDAS D-Dimer Exclusion is the most-referenced quantitative D-dimer assay on the market and is supported by multiple prospective management studies. In these studies, physicians adapted their decisions to eliminate further investigations on the basis of a PTP assessment 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, published in The American Journal of Medicine (2004; 116:291-29), included 965 patients with suspected pulmonary embolism. The level of sensitivity obtained with VIDAS D-Dimer Exclusion in this study was 100%. Such management studies have yielded data that has enabled bioMérieux to obtain FDA clearance, in conjunction with a PTP model, for the exclusion of DVT and PE in outpatients.
The new FDA clearance, which adds PE to the already-cleared DVT exclusion intended use, affirms VIDAS D-Dimer Exclusion as the gold standard reference assay for the exclusion of VTE. To reflect this intended use and to remind laboratorians and emergency clinicians that they can safely use the product with the confidence of the claim, bioMérieux recently changed VIDAS D-Dimer’s name from “New” to “Exclusion.” Only the name has changed, the product remains completely the same. VIDAS D-Dimer Exclusion still provides easy-to-use, single-dose reagents and an automated, rapid ELISA result in under one hour.
*See package insert.
1. Perrier A, et al. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet. 1999; 353: 190-195.