CINCINNATI--(BUSINESS WIRE)--Sep. 17, 2009--
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today
announced that the company has been granted a Special 510(k) clearance
to update the TRU FLU package insert to include analytical sensitivity
claims with two strains of 2009 H1N1 virus cultured from positive
respiratory specimens. TRU FLU is a rapid test which identifies
influenza A and B in human specimens.
Meridian’s TRU FLU and TRU RSV® products are unique in that
they feature a closed test system that allows a specimen to be contained
within the device once it has been inserted. While the performance
characteristics of the device with clinical specimens that are positive
for the 2009 H1N1 influenza virus have not been established, the
analytical sensitivity claims with the two strains adds an additional
important product benefit.
John A. Kraeutler, Chief Executive Officer, commented, “Meridian is
working diligently to provide our global customers who are facing an
influenza pandemic with product features that will assist them from a
testing standpoint. We must provide our customers with tools that allow
them to do their jobs in a rapid, safe and effective manner, thus
improving patient care.”
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, physician offices, 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.
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 can change expected results, as well as adverse trends
in buying patterns from customers. 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 successfully
integrated into Meridian's 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 which are incorporated by reference
into this press release.
Source: Meridian Bioscience, Inc.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive
Officer, 513-271-3700