Meridian Bioscience (VIVO) Gets FDA Clearance for ImmunoCard C. difficile GDH

December 27, 2011 11:16 AM EST
Meridian Bioscience, Inc., Cincinnati, Ohio (Nasdaq: VIVO) has received FDA clearance for a new Clostridium difficile assay, ImmunoCard C. difficile GDH. This test detects the C. difficile common antigen glutamate dehydrogenase (or GDH). This assay has already been successfully launched and accepted in global markets as an excellent screening option for C. difficile. The GDH common antigen is present in both toxigenic and nontoxigenic strains of C. difficile. Toxigenic strains of C. difficile are frequently associated with hospital and community-acquired diarrhea and can lead to life-threatening complications or death. Therefore, laboratories can use this highly sensitive screening test to identify patients with a suspected C. difficile infection and then reflex positives to a sensitive and more specific molecular assay like illumigene® C. difficile, which can confirm infection with the toxin-producing strains. Meridian Bioscience is the only manufacturer that can provide a complete portfolio of C. difficile testing solutions that meets the needs of its global customers. ImmunoCard C. difficile GDH, used in conjunction with illumigene C. difficile, empowers cost-sensitive laboratories with an economical algorithmic option for C. difficile diagnostic testing.

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