CINCINNATI--(BUSINESS WIRE)--
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today
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.”
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
Source: Meridian Bioscience, Inc.
