CINCINNATI--(BUSINESS WIRE)--June 12, 2006--Meridian Bioscience,
Inc. (NASDAQ:VIVO) today announced that it has received CLIA waiver
status from the U.S. Food and Drug Administration (FDA) for its
ImmunoCard STAT!(R) HpSA test, a rapid single-use test for the
diagnosis of Helicobacter pylori (H. pylori) infection. The vast
majority of peptic ulcer disease is caused by infection with H. pylori
bacteria and, in recent years, effective therapies have become
available for eradicating this disease. Peptic ulcer disease impacts
millions of Americans resulting in more than $6 billion in healthcare
costs each year. ImmunoCard STAT! HpSA is simple to use and provides
accurate results in just minutes from a non-invasive patient sample.
This test uses patented technology similar to that used in Meridian's
Premier Platinum HpSA(R) test and its use is indicated in the
diagnosis of H. pylori infection as well as for monitoring patient
response to therapy.
CLIA waiver status means that now doctors' offices can employ
"test and treat" medicine designed to eradicate infection while
reducing future risk significantly and reducing healthcare costs.
"ImmunoCard STAT! HpSA offers superior accuracy in a simple format
that makes the test ideally suited for smaller volume labs that
perform one or two tests at one time," stated John Kraeutler,
President and Chief Operating Officer. "Recently, the American
Gastroenterological Association issued important guidelines that
recommend against the use of tests that detect H. pylori antibodies
and support the use of direct H. pylori tests (e.g., ImmunoCard STAT!
HpSA and Premier Platinum HpSA Plus) prior to prescribing
symptom-relieving drugs. Having received this important CLIA waiver
status, Meridian will immediately expand its distribution partnerships
to increase access into the physicians' office and clinic markets."
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 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 are
based upon current expectations of the Company and speak only as of
the date made. The Company assumes no obligation to publicly update
any forward-looking statements. These statements are subject to
various risks, uncertainties and other factors that could cause actual
results to differ, 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. 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 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.
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 diagnostic products and tests provide accuracy,
simplicity and speed in the early diagnosis and treatment of common
medical conditions, such as gastrointestinal, viral, urinary and
respiratory infections. Meridian 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 National Market, symbol
VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, 513-271-3700
SOURCE: Meridian Bioscience, Inc.