Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced that it has
received FDA clearance from the U.S. Food and Drug Administration (FDA)
for a new rapid test for Campylobacter, ImmunoCard STAT!®
CAMPY. This new test provides fast and accurate detection of Campylobacter
bacteria, one of the most common causes of diarrheal illness and the
most common bacterial cause of foodborne illness in the United States.
Approximately 20 million stool culture tests are conducted each year in
the U.S. to detect the illness, known as Campylobacteriosis. Campylobacter
is most often transmitted by poorly cooked poultry or person-to-person
contact.
There is a real need for the ImmunoCard STAT!® CAMPY
because of its simplified, easy to perform procedure that provides
patient results in 20 minutes. In addition, ImmunoCard STAT!®
CAMPY provides a solution to several concerns associated with culture
testing, currently the most commonly practiced lab technique for
detecting the Campylobacter bacteria. With culture, there is a
potential for reduction in sensitivity due to variable culturing
procedures, specimen viability, and inhibitory antibiotics in culture
media. ImmunoCard STAT!® CAMPY dramatically reduces
these concerns with a consistent method that measures the bacterial
antigen instead of measuring the viability of this fragile bacteria in
an environment that is less inhibitory than current culturing procedures.
John A. Kraeutler, Chief Executive Officer, stated, “ImmunoCard
STAT!® CAMPY is a significant addition to our foodborne
category because it provides laboratories with a rapid, accurate and
easy to perform platform for the detection of Campylobacter. This
innovative assay, along with Meridian's Premier™ CAMPY and toxigenic E.
coli tests, demonstrates Meridian’s emerging leadership in foodborne
testing. ImmunoCard STAT!® CAMPY is already in
distribution by Meridian Bioscience Europe for the Company’s European
markets and was also recently approved for sale in Canada.”
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 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,
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 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