Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene® Mycoplasma
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
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.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded on NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700