CINCINNATI--(BUSINESS WIRE)--
Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that it has
successfully completed beta trials for two new illumigene molecular
amplification tests. These assays are designed to
specifically detect the DNA of Chlamydia trachomatis and Neisseria
gonorrhoeae, respectively, from both swab and urine samples.
For the first time, these two new assays will also incorporate Meridian
Bioscience’s new nucleic acid preparation device which further
simplifies the illumigene test procedure. This novel
sample preparation device does not require excessive sample manipulation
steps, such as centrifugations or washing, and takes only five minutes
to process a clinical specimen. In the beta trial, performance of the
new illumigene assays was assessed against two
market-leading molecular platforms on a statistically significant cohort
of symptomatic patients. The trials were successful and satisfied
the design criteria for both assays. Total test time, from specimen to
results, for these new illumigene molecular tests was
approximately one hour on the illumipro-10™ Integrated
Incubator/Reader. It is expected that the clinical trials for regulatory
submission will begin later in the second quarter and should be
completed later in the third quarter.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)
infections are two of the most common sexually transmitted infections
worldwide. The WHO (World Health Organization) estimates that 92 million
new cases of Chlamydia trachomatis and 62 million new cases of Neisseria
gonorrhoeae occur every year. It is estimated that 4 million
Americans are infected each year by Chlamydia trachomatis and 1
million infected by Neisseria gonorrhoeae. CDC reported
1.2 million cases of Chlamydia in 2009 in the US, yet data
indicate that more than half of sexually active individuals are
undiagnosed.
Jack Kraeutler, Chief Executive Officer stated, “Since its market
introduction two years ago, the illumigene system has
enabled more than 950 acute care laboratories to adopt molecular
amplification testing without capital outlays and costly service
contracts. Since the launch of illumigene C. difficile,
our menu has rapidly expanded to include: a specific claim for testing
pediatric patients for C. difficile; illumigene
Group B Strep for prenatal testing; and, illumigene Group
A Strep which is useful either as a primary test or as a confirmatory
test in place of a two-day culture. In addition, the illumigene
Mycoplasma pneumonia test has been submitted to the FDA, and we
expect to submit our illumigene Pertussis assay to the
Agency later in the second fiscal quarter. The illumigene
system provides our lab customers with an essential capability for
improving the diagnosis of infectious diseases thereby helping to lower
the overall costs of healthcare delivery.”
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. Meridian
relies on proprietary, patented and licensed technologies, and the
Company’s ability to protect its intellectual property rights, as well
as the potential for intellectual property litigation, would impact its
results. 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, including those
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. The international scope of Meridian’s
operations, including changes in the relative strength or weakness of
the U.S. dollar and general economic conditions in foreign countries,
can impact results and make them difficult to predict. One of Meridian’s
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 impact 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 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 through
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.
