FDA clears Meridian Bioscience's new illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc.,Jul 14 2010

Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its new molecular amplification assay, illumigene™ C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon. The illumigene molecular amplification assay detects the presence of the toxin producing region from the C. difficile DNA, and provides highly accurate results in under an hour. Meridian, a leading manufacturer of rapid immunoassay C. difficile tests, expands its existing portfolio with this new, simpler molecular assay. As a result, the Company will be uniquely positioned in the market to provide a full line of testing solutions that will meet the needs of its domestic and international customers.

The new illumigene C. difficile molecular diagnostic system provides high levels of sensitivity for diagnosing this serious, infectious disease. Its simple workflow requires minimal hands-on time per sample. The product has been recently launched successfully in Europe.

Jack Kraeutler, Chief Executive Officer, commented, "Some years ago, Meridian recognized that our infectious disease lab customers may require molecular amplification capabilities in specific instances. Our goal has been to deliver the power of molecular amplification in a platform that is simple, highly cost effective, and accessible for any of our lab customers. With the introduction of illumigene C. difficile, we have achieved the first step towards that goal. We look forward to the success of illumigene C. difficile, and we will be expanding the test menu for this exciting new platform."