Ohio-based Meridian Bioscience, a manufacturer of rapid immunoassay C difficile tests, has received FDA clearance for its new molecular amplification assay, illumigene Clostridium difficile. The illumigene assay detects the presence of the toxin producing region from the C difficile DNA.
Meridian Biosciencesaidthat the new illumigene C difficile molecular diagnostic system also provides high levels of sensitivity for diagnosing the serious, infectious disease. Its simple workflow requires minimal hands-on time per sample. The product has been recently launched successfully in Europe.
Meridian has expanded its existing portfolio with the new, simpler molecular assay. As a result, the company will be positioned in the market to provide a full line of testing solutions that will meet the needs of its domestic and international customers.
Jack Kraeutler, CEO, said: “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.”