| Durham, NC (July 2004) – bioMérieux, Inc. 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 in the U.S. 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 VTE 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.
About bioMérieux:
As a major player in the field of in vitro coagulation and infectious
disease diagnostics, bioMérieux designs, develops, manufactures
and markets reagents and automated instruments for medical analyses
and for cosmetics, and product quality control in the agri-food,
cosmetics and pharmaceutical industries.
bioMérieux is based in Marcy-l'Etoile, France, and has
14 production sites distributed in France, the Netherlands,
the United Kingdom, Italy, the United States, Brazil, Japan
and Australia, as well as a European logistics center in France.
*See package insert.
1. Perrier A, et al. Non-invasive diagnosis of venous thromboembolism
in outpatients. Lancet. 1999; 353: 190-195.
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