Meridian Bioscience seeks FDA marketing clearance for illumigene C. difficile molecular diagnostic test

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.

John A. Kraeutler, Chief Executive Officer, said, “Our R&D team has worked diligently for the past four years to refine and simplify this technology. The workflow is straight-forward so that the benefits of molecular diagnostics can be made available to any lab. The clinical trials that support the performance of illumigene were thorough and we are pleased with the performance of the test. We look forward to receiving clearance from the FDA and to the U.S. market introduction later this year.”