FDA Clearance for New illumigene™ C.difficile Pediatric Claim

A new pediatric claim for the illumigeneC. difficile molecular amplification test from Meridian Bioscience has received FDA clearance. The illumigenemolecular 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 illumigenetest is the only C. difficile test that is cleared by the FDA for use on children under the age of two.

Recent epidemiological data have indicated that the rate of community associated pediatric C. difficile increased by more than seventy percent from 1997 through 2006, which in turn is leading to increased hospitalizations among children. Rapid and accurate detection of C. difficile is critical in determining proper patient treatment. Meridian's new illumigeneC. difficile test provides a high level of sensitivity, with a simple workflow requiring less than two minutes of hands-on time per sample. The Company's illumigeneC. difficile test is available world-wide and its performance and customer acceptance has been very positive.