Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene Mycoplasma

21 Jun 2013
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Meridian Bioscience, Inc., has announced that it has received FDA clearance for a new molecular diagnostic test for Mycoplasma pneumonia (M. pneumoniae), its fourth assay on the illumigene platform. This innovative test that aids in identifying an important respiratory pathogen is a strong addition to the illumigene platform.
 
Often referred to as “walking pneumonia”, M. pneumoniae has been associated with up to 40% of community-acquired pneumonias. Infection occurs in both children and adults without geographical, gender or climate-related restrictions. M. pneumoniae is most often associated with atypical pneumonia, presenting with symptoms that include headache, malaise, myalgias, fever, and sore throat accompanied by dry, paroxysmal cough. An estimated 2 million cases of M. pneumoniae infection occur annually with approximately 100,000 pneumonia-related hospitalizations in the United States each year. An estimated 18% of M. pneumoniae cases in children require hospitalization.

illumigene Mycoplasma, by amplifying the specific DNA for the detection of Mycoplasma pneumoniae, represents a significant advancement in improving healthcare diagnoses and outcomes by providing a definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. M. pneumoniae bacterial culture lacks sensitivity and is often impractical for patient management as the organism may take as long as up to six weeks to culture.

The illumigene Mycoplasma test is the fourth assay on the illumigene platform and utilizes both throat and nasopharyngeal swab samples. The test procedure is remarkably simple and highly sensitive, allowing the flexibility of multiple specimen types. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. The simplicity of this technology, along with its cost efficiency and small footprint, makes this innovative test ideal for enabling a more rapid diagnosis; providing earlier identification of outbreaks and prevention of secondary cases though implementation of control measures.

“Up to 40% of community-acquired pneumonia is caused by Mycoplasma pneumoniae and due to rising rates of M. pneumoniae resistance to the macrolides commonly prescribed, the more rapid and accurate result that the illumigene Mycoplasma assay provides will allow for better patient care and safety,” stated Dr. Paul Lephart, Associate Technical Director of Microbiology, Detroit Medical Center University Laboratories.

John A. Kraeutler, Chief Executive Officer, stated, “As a significant cause of community-acquired pneumonia, Mycoplasma pneumoniae is under-diagnosed and under-reported. With illumigene Mycoplasma, laboratories can offer healthcare providers fast, accurate information so that patients may receive a definitive diagnosis and rapid, appropriate antibiotic therapy. Meridian is dedicated to the development of rapid, simple, cost effective diagnostic tests and technologies that aid in the reduction of overall healthcare costs. illumigene Mycoplasma will be available for delivery to our customers by month end.”

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Sonia Nicholas
Clinical Diagnostics Editor