Meridian Bioscience Receives FDA Clearance for New Premier C. difficile GDH Assay

Meridian Bioscience, Inc. announces that it has received clearance from the Food and Drug Administration (FDA) for a new Clostridium difficile immunoassay, Premier C. difficile GDH. This product expands the companys existing portfolio of C. difficile tests and has been available in Europe and the rest of world since October 2010. The assay detects a common antigen produced by toxigenic and non-toxigenic forms of C. difficile bacteria. Toxigenic forms of C. difficile are frequently associated with hospital and community acquired diarrhea resulting from antibiotic therapy and, in severe cases, can cause a life-threatening inflammation of the colon. Premier GDH is used by laboratories that want to screen patients with diarrhea for both forms of C. difficile. To differentiate those patients at risk of disease with toxin-producing forms of C. difficile, GDH-positive samples should be re-tested with toxin-detecting tests such as Meridians Premier Toxins A&B or ImmunoCard® Toxins A&B, or with a molecular amplification assay, such as Meridians illumigene® C. difficile test.

"C. difficile can be a very dangerous infection that may lead to severe consequences for both patients and the healthcare institutions that care for them," says CEO Jack Kraeutler. "Clearance of our new Premier C. difficile GDH test continues the companys long history of breakthrough products for the detection and identification of C. difficile. Meridian introduced its first latex based assay in March, 1990. Shortly thereafter, Meridian scientists confirmed that the "latex-reactive protein" of C. difficile was in fact a glutamate dehydrogenase and not a toxin, as previously thought. Continuing innovation allowed Meridian to launch the first commercially available GDH enzyme immunoassay (ImmunoCard® C. difficile GDH) in January 1993 that was significantly more sensitive than the previous latex based tests. This third generation GDH assay, built on 20 years of C. difficile expertise, should set a new standard for GDH identification and, along with our toxin detection assays and our new illumigene® molecular platform, affirms our unique position as the one IVD company that offers complete solutions for C. difficile detection."