bioMérieux Receives FDA Clearance for Expanded Claims with VIDAS® C. difficile Toxin A&B, Enhancing Testing Solutions for Hospital Infection Control

bioMérieux, a world leader in the field of in vitro diagnostics, is bringing a new, rapid solution to the fight against healthcare-associated infections, following clearance from the U.S. Food & Drug Administration (FDA) for expanded claims with VIDAS C. difficile Toxin A&B (CDAB). The VIDAS® C. difficile Toxin A&B assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).

The VIDAS® C. difficile Toxin A&B assay offers rapid detection of C. difficile, bacteria responsible for fatal epidemics of healthcare-associated infections in Canada, the United States and Europe and the most common cause of antibiotic-associated diarrhea in hospitals. In recent years, the incidence of C. difficile has increased and evolving strains, such as the highly virulent type O27, can increase risk for pseudomembranous colitis, sepsis and even death. Used with the automated VIDAS® system, the VIDAS® C. difficile Toxin A&B test provides results in 75 minutes (as opposed to 24 to 48 hours using the cytotoxicity reference method). This enables physicians to administer proper treatment and implement appropriate infection control measures (isolation, hygiene, disinfection) to prevent outbreaks.

“The fight against healthcare-associated infections is a strategic disease area for bioMérieux,” said Herb Steward, executive vice president and general manager, bioMérieux North America. “We have the most comprehensive diagnostic solution on the market to help hospitals and healthcare facilities fight healthcare-associated infection. We are pleased to respond to a growing concern for our customers and patients with the new VIDAS® C. difficile Toxin A&B.”

bioMérieux's VIDAS® C. difficile Toxin A&B is the only automated test on the market today, making bioMérieux the first company to offer a complete solution for managing C. difficile infections, including culture based identification with the API® 20A strip and automated bacterial genotyping with the DiversiLab® system.

About bioMérieux

A world leader in the field of in vitro diagnostics for 45 years, bioMérieux is present in more than 150 countries through 38 subsidiaries and a large network of distributors. In 2007, revenues reached €1.063 billion with 84% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software), which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on the NYSE Euronext Paris market (Code: BIM – Code ISIN: FR0010096479). Other information can be found at www.biomerieux.com.

Media Contacts

Fleishman-Hillard
Tim Baker
Tel: + 1 216-338-8086
Tim.Baker@fleishman.com

bioMérieux
Allan Mohess
Tel: + 1 919-620-2937
allan.mohess@na.biomerieux.com