Meridian Bioscience Comments on FDA Matter Involving its Subsidiary, Magellan Diagnostics
May 17 2017 - 3:30PM
Meridian Bioscience, Inc. (NASDAQ:VIVO). Meridian Bioscience,
Inc.’s subsidiary, Magellan Diagnostics, Inc., is currently working
with the U.S. Food and Drug Administration (FDA) regarding use of
venous blood (blood drawn from a vein) with its LeadCare Testing
Systems. Magellan’s primary product is the LeadCare II, a
point-of-care (CLIA-waived) blood lead testing system, on which the
vast majority of tests are performed with capillary blood
samples. Capillary samples are not affected by this
notification. In addition to LeadCare II, Magellan
Diagnostics has three moderately complex systems in use – LeadCare
Ultra and LeadCare Plus, which were cleared by FDA in 2013 and
2015, respectively, and the original LeadCare, launched in 1997 and
which the company has been phasing out. In contrast to the
LeadCare II, these systems are used in laboratory settings where
both venous and capillary samples are analyzed.
Today, FDA issued a warning that the results
from venous samples may be underestimated and provide inaccurate
results. Magellan is currently undertaking efforts to move
customers to capillary blood testing (fingerstick) with the
LeadCare II testing system as a corrective action in response to
the FDA warning. The LeadCare II System was designed to help
ensure broad-based blood lead screening is available by providing a
quick, easy and accurate way to identify children, pregnant women
and adults at risk for lead exposure. Magellan remains committed to
the importance of providing accurate results at the point of care,
as this creates the best opportunity to facilitate patient
education and intervention.
Venous blood sample testing on Magellan’s
systems consists of approximately 10% of Magellan’s revenue and
approximately 1% of Meridian’s overall revenue. Meridian and
Magellan do not expect this occurrence to cause any material
adverse effect to Meridian’s financial results. Meridian and
Magellan take these matters very seriously and will continue to
work closely and fully with the FDA and CDC to address the concerns
identified with venous samples as quickly as possible.
FORWARD-LOOKING STATEMENTSThe
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 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 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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