FDA clears Meridian's illumigene C. difficile molecular amplification test

Mar 2 2011

Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: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.

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 illumigene C. 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 illumigene C. difficile test is available world-wide and its performance and customer acceptance has been very positive.

Jack Kraeutler, Chief Executive Officer, commented, "Meridian is constantly working to provide our global customers innovative products that truly address their needs. As we monitored the C. difficile market, we recognized and acted upon the increasing prevalence of pediatric C. difficile in order to be able to address the growing needs of our clinical lab customers. Recently, we have completed another clinical study that evaluated a large number of random specimens from patients suspected of having C. difficile disease. We discovered that approximately 12% of these specimens were from children under two years of age. This new pediatric indicator for illumigene C. difficile will provide our customers with a critical tool to help detect and manage this devastating infection in young children. The early success of the illumigene technology, along with new claims and additional tests to be introduced in the near future using the illumigene technology, confirms our commitment to this unique molecular amplification technology."