FDA Approved VIDAS® C. difficile GDH is the 100th VIDAS® Assay
bioMérieux has launched the VIDAS® C. difficile GDH*, making it the only company with the width to provide solutions for C. difficile according to different laboratory settings, patient conditions and medical needs.
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.1 VIDAS® C. difficile GDH has received CE marking and is the only automated immunoassay cleared by the 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.
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.
Tags: Clostridium difficile
Date Published: March 4, 2014
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