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bioMérieux Launches New Clostridium Difficile GDH Assay

bioMérieux, a world leader in the field of in vitro diagnostics, is pleased to announce that the launch of VIDAS® C. difficile GDH makes it the only company with the width to provide solutions for C. difficile according to different laboratory settings, patient conditions and medical needs.

Clostridium difficile is a bacterium recognized as the chief infectious cause of healthcare and antibiotic-associated diarrhea, mainly in elderly patients. In this context, diagnosing C. difficile infections is key to improve patient outcome and avoid complications and septicemia. In addition, an accurate and rapid diagnosis enables to stop contaminations at hospitals and reduce high financial expenses associated with such infections.

As the leader in clinical microbiology testing, bioMérieux's ambition is that every infectious disease laboratory will find a solution adapted to its need within bioMérieux C. difficile range of products. bioMérieux's offering already includes chromID® C. difficile culture media and VIDAS® C. difficile Toxin A&B assay for the detection of C. difficile Toxins A&B secreted by the bacteria. In line with this long-standing expertise in C. difficile control and detection, bioMérieux recently launched VIDAS® C. difficile GDH, for the automated detection of GDH, a specific enzyme produced by C. difficile. This innovative, qualitative assay will be used as an aid in the diagnosis and treatment of C. difficile infections in complement to other C. difficile assays. The combination of tests based on GDH, then toxin detection, is recommended by leading international experts as the most valuable C. difficile diagnosis solution. VIDAS® C. difficile GDH has received CE marking and is the only automated immunoassay cleared by the U.S. Food and Drug administration (FDA).

VIDAS® C. difficile GDH was developed and is produced by bioMérieux in France at its Marcy l'Etoile site, where the Company's global headquarters are located. VIDAS® C. difficile GDH is used on the VIDAS®, mini VIDAS® and VIDAS® 3 automated immunoassay platforms, providing clinical laboratories with a fully automated, accurate, standardized and cost-effective solution for C. difficile diagnosis and infection control. With a reputation for quality and reliability, VIDAS® is the world's largest installed base of automated immunoassay systems in clinical laboratories.

"C. difficile infections are a major concern for both health professionals and hospitalized patients, and are a leading cause of healthcare-associated infections", said Mark Miller, bioMérieux's Chief Medical Officer. "We are extremely pleased to enrich our VIDAS® menu with this new test, a welcome addition for our existing offer. Many clinical laboratories will now be able to perform the complete C. difficile detection, based on bioMérieux's solutions. With this new launch, bioMérieux shows its commitment to the fight against C. difficile infections, providing clinical laboratories with a global offer for C. difficile infection diagnosis and management."

bioMérieux now offers a full solution for C. difficile, from identification to epidemiology, in order to answer to all customer needs in all infectious disease laboratories: chromID® C. difficile culture media for identification, VIDAS® C. difficile GDH and VIDAS® C. difficile Toxin A&B for automated and cost-effective identification, Etest® for antibiotic susceptibility testing and DiversiLab®, an epidemiological tool for strain typing. This range should soon be enlarged by the FilmArray® Gastrointestinal (GI) Panel, a molecular diagnostics system enabling to rapidly identify pathogens responsible for infectious diarrhea, including C. difficile, in emergency or critical situations. This panel has just been submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.

* Glutamate dehydrogenase

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