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.”
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