Meridian Initiates Clinical Trials for New Neonatal Saliva CMV illumigene Test
August 09 2017 - 1:30PM
Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that it has
initiated clinical trials for a new
illumigene CMV
molecular amplification test. This assay is designed to
specifically detect the congenital Cytomegalovirus (CMV) infection
in newborns from saliva. Presently, there is no FDA-cleared test
for CMV screening in newborns. Meridian has enrolled an
international team of world experts in neonatal CMV infections in
order to support the clinical studies.
According to the CDC, congenital CMV infection
occurs when a baby is born with a Cytomegalovirus infection. About
one out of every 200 babies are born with congenital CMV infection.
Women can pass CMV to their baby during pregnancy if the virus in
the woman’s blood crosses through the placenta and infects the
baby. Congenital CMV infection can cause developmental disabilities
such as hearing and vision loss, cerebral palsy, mental disability,
and in rare cases, death. Early detection is integral in
establishing appropriate treatment. Congenital CMV can be diagnosed
if the virus is detected in a baby’s urine or saliva, within 2 to 3
weeks from birth. CMV is a public health issue and legislation has
been passed or is under consideration in numerous states regarding
CMV education and testing in neonates.
Richard L. Eberly, President, Chief Commercial
Officer, stated, “We are excited to initiate clinical trials for
this important new test as part of our commitment to expand the
menu of illumigene to include new and novel ways
of improving healthcare and impacting human lives.”
John A. Kraeutler, Chief Executive Officer and
Chairman of the Board said, “We support testing for neonates and
are excited to progress to the clinical trial phase with
illumigene CMV. We believe the CMV market is in
critical need of a procedurally simple, rapid, and sensitive test
that is saliva based. We look forward to a positive outcome of our
illumigene CMV clinical trial and subsequent
submission to the FDA.”
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
Meridian Bioscience (NASDAQ:VIVO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Meridian Bioscience (NASDAQ:VIVO)
Historical Stock Chart
From Apr 2023 to Apr 2024