Meridian Bioscience, Inc. (VIVO) Submits New illumigene(TM) Molecular C. difficile Test to U.S. FDA for Marketing Clearance
3/23/2010 11:09:19 AM
CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc. announced today that it has submitted a 510(k) application to the United States Food and Drug Administration for marketing clearance of its new, simple molecular diagnostic test, illumigene™ C. difficile. illumigene is a simplified new technology platform, based upon loop amplification (LAMP) that makes molecular diagnostic testing possible for any size laboratory. The technology is isothermal and therefore requires no costly capital equipment. Clostridium difficile is a major cause of antibiotic associated diarrhea and it is the primary cause of pseudomembranous colitis. C. difficile bacteria can produce toxins that attack the cell walls of an infected patient’s intestines causing serious and often life-threatening damage. This first molecular amplification test from Meridian, illumigene C. difficile, detects and amplifies a pathogenic DNA region common to all toxin-producing strains of C. difficile. The test is performed on a small sample of the patient’s stool and the entire procedure can be completed in less than one hour.
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