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DURHAM, N.C. (February 22, 2005) - bioMérieux, Inc. today announced it has received the 2004 Product Innovation of the Year Award for Clinical Diagnostics. The company, based in France, with North American headquarters in Durham, North Carolina, was given the award based on its work in developing and commercializing the VIDAS® D-Dimer ExclusionT assay. This award is presented annually to the company that has demonstrated excellence in new products and technologies within their industry by launching a novel product that has had a profound impact.
"Following an exhaustive review process, this award is bestowed on the company that successfully develops a product that is believed to provide a unique set of benefits over existing products on the market," said Dhiraj Ajmani, healthcare industry manager with Frost & Sullivan.
Eric Bouvier, bioMérieux's North American president and CEO, added, " Receiving this award underscores our commitment to research and innovation ."
VIDAS D-Dimer Exclusion is the only rapid automated enzyme linked immunosorbent assay (ELISA) cleared by the U.S. Food and Drug Administration (FDA) for the exclusion of a diagnosis of both deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients when used in conjunction with a pre-test probability assessment. The test has more than 99 percent negative predictive value (NPV) and provides results within an hour.
The clearance was granted for DVT in September 2003 and for PE in June 2004. VIDAS D-Dimer was first released in the U.S. market in 1999 and is the most referenced quantitative D-dimer assay in the market. Although there are a number of multinational companies in the clinical diagnostics market, none of bioMérieux's competitors has a D-dimer assay that is cleared by the FDA for this dual exclusion claim.
DVT and PE are collectively classified as venous thromboembolism (VTE). According to the American Heart Association, approximately 250,000 Americans are hospitalized annually with VTE. It is estimated that death occurs within one month of diagnosis2 in about six percent of DVT cases and about 12 percent of PE cases.
The topic of DVT and PE appears in the news media frequently, with notable victims including NBC news correspondent David Bloom, former Minnesota Governor Jesse Ventura, and Olympic gold-medal skater Tara Lipinski. Bloom died as a result of a PE while covering the Iraq War in April, 2003. Both Ventura and Lipinski recovered. Airline travelers sometimes refer to DVT as the "economy class syndrome" because the condition has been associated with long periods spent immobile and in cramped conditions such as those experienced in the tightly packed seating that can be found in the economy class section of airplanes.
Approximately 75 percent of patients suspected of having VTE actually do not have the condition but could be subjected to a series of expensive and potentially risky tests2 to rule it out. They could even undergo unnecessary treatment because the condition can be difficult to diagnose. New algorithm based on clinical pre-test probability and D-Dimer testing has been shown to be safe and reduced the cost for diagnosing VTE4, reduces the length of stay in emergency departments, and saves money on staff and resources. Now, with VIDAS D-Dimer Exclusion, clinicians can safely and reliably rule out DVT and PE in 30-40 percent of suspected outpatients3, 5.
bioMérieux's web site provides more information at www.biomerieuxusa.com/clinical/coagulation/vidas_ddimer_exclusion/index.htm .
bioMérieux has seen rapid acceptance of VIDAS D-Dimer Exclusion in the market, especially with emergency department physicians, who request diagnostic testing from the hospital laboratories. bioMérieux has developed a very valuable and significant product in the form of VIDAS D-Dimer Exclusion, which is why the company has been presented with the 2004 Frost & Sullivan Product Innovation of the Year Award.
About the Award
To choose the recipient of this award, the Frost & Sullivan analyst team tracks all new product launches, R&D spending, products in development, and new product features and modifications. This is accomplished through interviews with all the market participants, and extensive secondary and technology research. All new product launches and new products in development are compared and evaluated based on degree of innovation and customer satisfaction. Companies are then ranked based on the market influence of their innovation.
In addition to the methodology described above, there are specific criteria used to determine final competitor rankings in this industry. The recipient of this Award has excelled based on one or more of the following criteria:
- Significance of new product in their industry
- Competitive advantage of new product(s) in their industry
- Product innovation in terms of unique or revolutionary technology
- Product acceptance in the marketplace
- Value provided to customers
- Number of competitors with similar product(s).
About Frost & Sullivan
Frost & Sullivan, a global growth consulting company founded in 1961, partners with clients to
create value through innovative growth strategies. The foundation of this partnership approach is our
Growth Partnership Services platform, whereby we provide industry research, marketing strategies,
consulting and training to our clients to help grow their business. A key benefit that Frost &
Sullivan brings to its clients is a global perspective on a broad range of industries, markets,
technologies, econometrics, and demographics. With a client list that includes Global 1000 companies,
emerging companies, as well as the investment community, Frost & Sullivan has evolved into one of
the premier growth consulting companies in the world. For more information, visit www.frost.com.
About bioMérieux, Inc.
bioMérieux, Inc. is the U.S. subsidiary of bioMérieux S.A., a company headquartered in France. With sales of 930.6 million euros in 2004, bioMérieux is a leading international diagnostics group that specializes in the field of in vitro diagnostics for clinical and industrial applications. bioMérieux designs, develops, manufactures and markets systems (i.e. reagents, instruments and software) used in:
- Clinical applications: the diagnosis of infectious diseases such as hepatitis, HIV, tuberculosis and respiratory illnesses, as well as pathologies such as certain cardiovascular diseases and certain cancers, based on the analysis of biological samples (such as blood, saliva or urine); and
- Industrial applications: the microbiological analysis of food, environments (such as water and air), surfaces and pharmaceutical and cosmetic products, based on product or environmental samples.
bioMérieux is listed on the Premier Marché of Euronext Paris (symbol "BIM", ISIN code: FR0010096479).
Media Contacts:
1. American Heart Association: Venous Thromboembolism - Statistics.
2. Perrier A, et al., Non-invasive diagnosis of venous thromboembolism in outpatients, Lancet. 1999; 353:190-195.
4. Humphreys Ck, et al., Cost-minimization analysis of two algorithms for diagnosing acute Pulmonary Embolism, Thrombosis Research 2004; 113: 275-282.
3., 5. Perrier A, et al., Diagnosing Pulmonary Embolism in Outpatient with Clinical Assessment, Venous Ultrasound, and Helical Computed Tomography: A Multicenter Management Study, The American Journal of Medicine, 2004; 116: 291-299.
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