Meridian Bioscience, Inc., (NASDAQ:VIVO) today announced that it has received an approved medical device license from Health Canada 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. Having received this license, the Company will be uniquely positioned in the Canadian market to provide a full line of C. difficile testing solutions that meet the needs of its clinical lab 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 the U.S. as well as in Australia, Taiwan and most European markets.
Jack Kraeutler, Chief Executive Officer, commented, "Toxin producing C. difficile infections, especially in hospitalized patients, can have especially devastating consequences if not diagnosed and treated quickly. Because disease symptoms of C. difficile infection can strike patients at any hour of the day or night, Meridian designed illumigene C. difficile to enable real-time molecular testing in any lab at any time. With minimal hands-on time and virtually no capital expense, illumigene gives any infectious disease lab access to a convenient and powerful DNA amplification platform."
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