CINCINNATI, Mar 02, 2011 (BUSINESS WIRE) --
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today
announced that it has received clearance from the U.S. Food and Drug
Administration (FDA) for a new pediatric claim for its illumigeneC. difficile (Clostridium difficile) molecular
amplification test. C. difficile is a bacterium that is
frequently associated with antibiotic therapy often causing diarrhea
and, in severe cases, a life-threatening inflammation of the colon. The illumigenemolecular test is designed to target the region of the C.
difficile DNA that is presented in all toxin A and/or toxin B
producing strains. The illumigenetest provides
highly accurate results in under an hour. Meridian Bioscience's illumigenetest is the only C. difficile test that is cleared by the
FDA for use on children under the age of two.
Recent epidemiological data have indicated that the rate of community
associated pediatric C. difficile increased by more than seventy
percent from 1997 through 2006, which in turn is leading to increased
hospitalizations among children. Rapid and accurate detection of C.
difficile is critical in determining proper patient treatment.
Meridian's new illumigeneC. difficile test
provides a high level of sensitivity, with a simple workflow requiring
less than two minutes of hands-on time per sample. The Company's illumigeneC. difficile testis available world-wide and its
performance and customer acceptance has been very positive.
Jack Kraeutler, Chief Executive Officer, commented, "Meridian is
constantly working to provide our global customers innovative products
that truly address their needs. As we monitored the C. difficile
market, we recognized and acted upon the increasing prevalence of
pediatric C. difficile in order to be able to address the growing
needs of our clinical lab customers. Recently, we have completed another
clinical study that evaluated a large number of random specimens from
patients suspected of having C. difficile disease. We discovered
that approximately 12% of these specimens were from children under two
years of age. This new pediatric indicator for illumigene C.
difficile will provide our customers with a critical tool to help
detect and manage this devastating infection in young children. The
early success of the illumigene technology, along with new
claims and additional tests to be introduced in the near future using
the illumigene technology, confirms our commitment to this unique
molecular amplification technology."
FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe
harbor from civil litigation for forward-looking statements accompanied
by meaningful cautionary statements. Except for historical information,
this report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, which may be identified by words
such as "estimates", "anticipates", "projects", "plans", "seeks", "may",
"will", "expects", "intends", "believes", "should" and similar
expressions or the negative versions thereof and which also may be
identified by their context. Such statements, whether expressed or
implied, are based upon current expectations of the Company and speak
only as of the date made. The Company assumes no obligation to publicly
update or revise any forward-looking statements even if experience or
future changes make it clear that any projected results expressed or
implied therein will not be realized. These statements are subject to
various risks, uncertainties and other factors that could cause actual
results to differ materially, including, without limitation, the
following: Meridian's continued growth depends, in part, on its ability
to introduce into the marketplace enhancements of existing products or
new products that incorporate technological advances, meet customer
requirements and respond to products developed by Meridian's
competition. While Meridian has introduced a number of internally
developed products, there can be no assurance that it will be successful
in the future in introducing such products on a timely basis. Ongoing
consolidations of reference laboratories and formation of multi-hospital
alliances may cause adverse changes to pricing and distribution.
Recessionary pressures on the economy and the markets in which our
customers operate, as well as adverse trends in buying patterns from
customers can change expected results. Costs and difficulties in
complying with laws and regulations administered by the United States
Food and Drug Administration can result in unanticipated expenses and
delays and interruptions to the sale of new and existing products.
Changes in the relative strength or weakness of the U.S. dollar can also
change expected results. One of Meridian's main growth strategies is the
acquisition of companies and product lines. There can be no assurance
that additional acquisitions will be consummated or that, if
consummated, will be successful and the acquired businesses will be
successfully integrated into Meridian's operations. There may be risks
that acquisitions may disrupt operations and may pose potential
difficulties in employee retention and there may be additional risks
with respect to Meridian's ability to recognize the benefits of
acquisitions, including potential synergies and cost savings or the
failure of acquisitions to achieve their plans and objectives. The
Company cannot predict the possible effects of recently-enacted United
States healthcare legislation and any similar initiatives in other
countries on its results of operations. In addition to the factors
described in this paragraph, Part I, Item 1A Risk Factors of our Form
10-K contains a list and description of uncertainties, risks and other
matters that may affect the Company.
Meridian is a fully integrated life science company that 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,
veterinary testing centers, diagnostics manufacturers and biotech
companies in more than 60 countries around the world. The Company's
shares are traded through NASDAQ's Global Select Market, symbol VIVO.
Meridian's website address is www.meridianbioscience.com.
SOURCE: Meridian Bioscience, Inc.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700