CINCINNATI, May 10, 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 Clostridium difficile immunoassay
named Premier(TM) C. difficile GDH. This product expands the
Company's existing portfolio of C. difficile tests and has been
available in Europe and the rest of world since October of 2010. The
assay detects a common antigen produced by toxigenic and non-toxigenic
forms of C. difficile bacteria. Toxigenic forms of C. difficile
are frequently associated with hospital and community acquired diarrhea
resulting from antibiotic therapy and, in severe cases, can cause a
life-threatening inflammation of the colon. Premier(TM) GDH is used by
laboratories that want to screen patients with diarrhea for both forms
of C. difficile. To differentiate those patients at risk of
disease with toxin-producing forms of C. difficile, GDH-positive
samples should be re-tested with toxin-detecting tests such as
Meridian's Premier(TM) Toxins A&B or ImmunoCard(R)
Toxins A&B, or with a molecular amplification assay, such as Meridian's illumigene(R)C. difficile test.
Jack Kraeutler, Chief Executive Officer, commented, "C. difficile
can be a very dangerous infection that may lead to severe consequences
for both patients and the healthcare institutions that care for them.
Clearance of our new Premier(TM) C. difficile GDH test continues the
Company's long history of breakthrough products for the detection and
identification of C. difficile. Meridian introduced its first
latex based assay in March, 1990. Shortly thereafter, Meridian
scientists confirmed that the "latex-reactive protein" of C. difficile
was in fact a glutamate dehydrogenase and not a toxin, as previously
thought. Continuing innovation allowed Meridian to launch the first
commercially available GDH enzyme immunoassay (ImmunoCard(R)C. difficile GDH) in January 1993 that was significantly more
sensitive than the previous latex based tests. This third generation GDH
assay, built on 20 years of C. difficile expertise, should set a
new standard for GDH identification and, along with our toxin detection
assays and our new illumigene(R) molecular
platform, affirms our unique position as the one IVD Company that offers
complete solutions for C. difficile detection."
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
