Meridian Bioscience Receives FDA Clearance For New illumigene C. difficile Pediatric Claim

Meridian Bioscience, Inc., Cincinnati, Ohio VIVO today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for a new pediatric claim for its illumigene C. difficile (Clostridium difficile) molecular amplification test. C. difficile is a bacterium that is frequently associated with antibiotic therapy often causing diarrhea and, in severe cases, a life-threatening inflammation of the colon. The illumigene molecular test is designed to target the region of the C. difficile DNA that is presented in all toxin A and/or toxin B producing strains. The illumigene test provides highly accurate results in under an hour. Meridian Bioscience's illumigene test is the only C. difficile test that is cleared by the FDA for use on children under the age of two.