DURHAM, NC (September 27, 2006) - bioMérieux, Inc. has received FDA 510(k) clearance for laboratories to perform fluconazole susceptibility tests on the VITEK® 2 automated microbiology system. The fluconazole susceptibility tests will be used to determine the susceptibility of Candida species to this antifungal agent. The Fluconazole Minimum Inhibitory Concentration (MIC) Susceptibility test card for the VITEK 2 platform will provide an accurate, rapid and automated method for the susceptibility testing of systemic yeast infections, a growing cause of hospital-acquired infections (HAI).
The New England Journal of Medicine has identified Candida species as the fourth leading cause of nosocomial bloodstream infection in the United States. With the clearance of the first automated method for fluconazole susceptibility testing, clinicians can quickly ascertain if patients could be treated with fluconazole instead of one of the other more expensive drugs, such as the new echinocandin antibiotics or the more toxic drug, amphotericin.
Currently available manual methods for testing the susceptibility of yeasts to antifungal agents can be subjective, difficult to perform, labor intensive, and expensive. Often the results take several days or weeks to reach physicians. Therefore, many clinicians forego this testing and treat the patients empirically with expensive, broad spectrum, and/or toxic antifungal agents that may be unnecessary. bioMérieux’s VITEK 2 platform allows laboratories to provide physicians with fluconazole susceptibility test information against Candida species within 36 hours.
The Fluconazole MIC Susceptibility test is used in conjunction with the VITEK 2 Yeast Identification card to assist clinicians in the selection of optimal antifungal therapy. The correct speciation of yeast may also be an important determinant in selecting the most appropriate therapy, as certain species are intrinsically resistant to some antifungal agents.
“bioMérieux developed this card in an effort to improve the prudent use of antibiotics and to enhance the identification process for Candida species,” said Eric Bouvier, President, bioMérieux, Inc. “bioMérieux is dedicated to bringing technology to market that will help the healthcare industry address concerns such as emerging resistance, infection control, medication errors, and over-prescribing of antibiotics. Our goal is to ultimately improve patient care.”
The Fluconazole MIC Susceptibility test card will be available for VITEK 2 users in the near future and will be available for use with the VITEK 2 Compact in Q1 of 2007.
About bioMérieux, Inc. 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 cardiovascular diseases and cancer, 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 the analysis of product or environmental samples.
In 2005, bioMérieux sales reached 994 million euros. The company is present in more than 130 countries through 35 subsidiaries and a large network of distributors, which positions the company well to benefit from the growth potential of the in vitro diagnostics market. Some important drivers that underpin this growth are aging populations and age-related illness, illnesses related to life-style and eating habits, emerging new pathogens, the development of antibiotic-resistant bacteria, the fight against bio-terrorism, and the recognition of the importance of the quality of food products. bioMérieux is listed on the Eurolist of Euronext, Paris (FR0010096479 - BIM). Other information can be found at www.biomerieux-usa.com
Media Contacts: Paige Sargent French/West/Vaughan Tel.: 919-277-1162 psargent@fwv-us.com
bioMérieux: Christelle Chabert Tel. : +33 (0)4 78 87 52 01
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