Meridian Bioscience Introduces the Expansion of Its ImmunoCard STAT!® Product Line
August 08 2017 - 2:31PM
Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced the
expansion of its ImmunoCard STAT!® product line with the addition
of ImmunoCard STAT! FLU A&B. The ImmunoCard STAT! FLU A&B
product is CLIA waived and meets the new FDA reclassification
requirements. ImmunoCard STAT! FLU A&B detects the presence of
influenza A & B in nasal and nasopharyngeal swabs. The product
can also be used to test aspirates and nasal washes. The ImmunoCard
STAT! FLU A&B test has a simple procedure with minimal hands on
time that provides qualitative results in 10 to 15 minutes.
ImmunoCard STAT! FLU A&B meets the testing
needs of all point-of-care environments like CLIA-waived physician
offices, Emergency Rooms, moderately complex physician offices, and
the core hospital laboratory. ImmunoCard STAT! FLU A&B
compliments ImmunoCard STAT! EHEC, ImmunoCard STAT! Crypto/Giardia,
ImmunoCard STAT! CAMPY, ImmunoCard STAT! HpSA, ImmunoCard STAT!
Strep A, ImmunoCard STAT! Rotavirus, and ImmunoCard STAT! Mono.
The influenza testing landscape has changed
since the FDA issued a reclassification of the rapid influenza
virus antigen tests on January 12, 2017. In addition to
reclassifying such devices from Class I to Class II, the FDA has
put special controls in place that redefine sensitivity and
specificity performance criteria that must be met by the
manufacturers of rapid influenza devices after January 12, 2018.
The ImmunoCard STAT! FLU A&B CLIA-waived test meets the
criteria set by the FDA.
Charles Caso, Vice President Sales &
Marketing, Global Diagnostics, commented, “ImmunoCard STAT! FLU
A&B allows us to meet our current customer requirements and,
with CLIA waiver, opens up a whole new market for Meridian
Bioscience. We will begin taking orders immediately with ship dates
in early September.”
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. All statements that address operating
performance or events or developments that Meridian expects or
anticipates will occur in the future, including, but not limited
to, statements relating to per share diluted earnings and revenue,
are forward-looking statements. Such statements, whether
expressed or implied, are based upon current expectations of the
Company and speak only as of the date made. Specifically,
Meridian’s forward-looking statements are, and will be, based on
management’s then-current views and assumptions regarding future
events and operating performance. Meridian 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 actual results, financial condition,
or 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, and its ability to effectively sell such
products. 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 or in protecting its intellectual property.
Meridian relies on proprietary, patented and licensed technologies.
As such, 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, as can the
uncertainty of regulatory approvals and the regulatory
process. 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. Meridian cannot predict the outcome of goodwill
impairment testing and the impact of possible goodwill impairments
on Meridian’s earnings and financial results. Meridian cannot
predict the possible impact of U.S. health care legislation enacted
in 2010 – the Patient Protection and Affordable Care Act, as
amended by the Health Care and Education Reconciliation Act – and
any modification or repeal of any of the provisions thereof, and
any similar initiatives in other countries on its results of
operations. Efforts to reduce the U.S. federal deficit,
breaches of Meridian’s information technology systems and natural
disasters and other events could have a materially adverse effect
on Meridian’s results of operations and revenues. In addition
to the factors described in this paragraph, Part I, Item 1A Risk
Factors of our most recent Annual Report on Form 10-K, and other
periodic filings with the Securities and Exchange Commission
contain a list and description of uncertainties, risks and other
matters that may affect the Company. Readers should carefully
review these forward-looking statements and risk factors and not
place undue reliance on our forward-looking statements.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops,
manufactures, markets and distributes a broad range of innovative
diagnostic test kits, rare reagents, specialty biologicals and
components. Utilizing a variety of methods, our diagnostic tests
provide accuracy, simplicity and speed in the early diagnosis and
treatment of common medical conditions, such as infections and lead
poisoning. Meridian’s diagnostic products are used outside of the
human body and require little or no special equipment. The
Company's diagnostic products are designed to enhance patient
well-being while reducing the total outcome costs of health care.
Meridian has strong market positions in the areas of
gastrointestinal and upper respiratory infections, and blood lead
level testing. In addition, Meridian is a supplier of rare
reagents, specialty biologicals and components used by
organizations in the life science and agri-bio industries engaged
in research. Its products are also used by companies as components
in the manufacture of diagnostics. The Company markets its products
and technologies to hospitals, reference laboratories, research
centers, diagnostics manufacturers and agri-bio companies in more
than 70 countries around the world. The Company’s shares are traded
on the NASDAQ Global Select Market, symbol VIVO. Meridian's website
address is www.meridianbioscience.com.
Contact:
John A. Kraeutler
Chairman, Chief Executive Officer
Meridian Bioscience, Inc.
Phone: 513.271.3700
Email: mbi@meridianbioscience.com
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