Meridian Bioscience, Inc. today announced it 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(R) 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 illumigeneC. difficile, empowers cost-sensitive laboratories with an economical algorithmic option for C. difficile diagnostic testing.
Jack Kraeutler, Chief Executive Officer stated, "C. difficile continues to be both a dangerous and costly infection for patients and the healthcare institutions that care for them. For a screening test to be most effective, it must be very sensitive so as not to miss any true positives. In rigorous clinical studies, ImmunoCard C. difficile had the highest negative predictive value when compared against competing screening tests. The introduction of ImmunoCardC. difficile GDH in the US market continues Meridian's legacy of leadership in the detection and identification of C. difficile. This new product, along with the Meridian illumigeneC. difficile molecular assay, allows laboratories to identify C. difficile infected patients with a rapid screening test and molecular confirmation in less than two hours."