CINCINNATI--(BUSINESS WIRE)--Nov. 18, 2015--
Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced it has received
clearance from the U.S. Food and Drug Administration (FDA)
for new claims for its illumigene® Pertussis molecular
amplification test. The upgraded test reduces the effect of inhibitors
in biologic samples and significantly expands Meridian’s customer base
by including specimens collected by ESwab™ (Copan Diagnostics, Inc.).
ESwab is a multipurpose universal transport system that a significant
portion of laboratories in the United States currently use to streamline
workflows and eliminate costs associated with stocking multiple swab
Mike Shaughnessy, Executive Vice President and President of Meridian
Global Diagnostics stated, “We are pleased to be able to offer an
upgraded pertussis test that was developed with customer feedback in
mind. Continuous product improvement and development successes like this
illustrate Meridian’s commitment to our customers, and the patients that
they serve. Through efforts like these we believe we will continue to
grow our customer base and maintain our market leading position in
molecular pertussis testing.”
Often referred to as “whooping cough”, Bordetella pertussis can
cause serious illness in infants, children and adults. Each year, there
are approximately 16 million reported cases of pertussis worldwide and
nearly 200,000 deaths. In the United States alone, almost 33,000
pertussis infections were reported in 2014, which represents a 15%
increase compared to 2013.
illumigene Pertussis, by amplifying the specific DNA
target for the detection of Bordetella pertussis, provides a
definitive result, thus helping to ensure that patients receive the
appropriate antibiotic therapy in a timely manner. By comparison, B.
pertussis bacterial culture lacks sensitivity and is often
impractical for patient management. Also, healthcare providers that send
out to reference laboratories may have to wait more than a week for a
test result delaying the necessary treatment for the patient.
The illumigene Pertussis test procedure is remarkably
simple, taking less than sixty minutes to report up to 10 results. It
requires no expensive capital equipment, and no costly annual service
contracts. The simplicity of this technology, along with its cost
efficiency and small footprint, makes this innovative test ideal for
enabling a more rapid diagnosis.
Meridian is a fully integrated life science company that develops
markets and distributes a broad range of innovative diagnostic tests,
purified reagents and related products and offers biopharmaceutical
enabling technologies in more than 60 countries worldwide. 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 health care. 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. For more information please visit www.meridianbioscience.com.
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Source: Meridian Bioscience, Inc.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive