Meridian Gets FDA Clearance for New Neonatal Saliva CMV Test
December 06 2018 - 7:30AM
Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced that it
has received FDA clearance for its new Alethia™ CMV Molecular
Amplification Test (formerly, the
illumigene
brand). This assay is designed to specifically detect congenital
Cytomegalovirus (cCMV) infection in newborns from an
easy-to-collect saliva sample. Alethia CMV is the first qualitative
test in a molecular amplification format, FDA-cleared for cCMV
testing in newborns.
Congenital CMV is the most common congenital
infection and a leading cause of childhood hearing loss, cognitive
deficits, and visual impairment. According to the CDC about 1 out
of every 200 babies are born with cCMV infection; and approximately
10% to 25% of all childhood sensorial hearing loss (SNHL) can be
attributed to cCMV. Babies are at risk of infection during
pregnancy if the virus in the mother’s blood crosses through the
placenta. Early detection is critical in establishing appropriate
treatment. Diagnosis can be attained by detecting the virus in a
baby’s saliva or urine 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 recommendations in neonates.
Lawrence Mertz, Senior Vice-President of
Research and Development, stated, “We are excited to be the first
to develop and bring to market a very important test for newborns.
It is an advancement in testing for a viral infection that can lead
to such complicated and long-lasting conditions in children.”
Jack Kenny, Chief Executive Officer, said,
“Unfortunately cCMV infection is more common than other newborn
related illnesses, like Group B Strep for example, yet the level of
awareness is considerably lower. With Alethia CMV, we not only look
to increase awareness, but also provide laboratories with an
FDA-cleared test that they can use with confidence when diagnosing
newborns with cCMV. Alethia CMV helps meet a critical need with a
simple-to-collect saliva sample in combination with a procedurally
simple, rapid, and sensitive test. Alethia CMV marks the launch of
the new branding for our current molecular platform.”
About Meridian Bioscience,
Inc.
Meridian is a fully integrated life science
company that develops, manufactures, markets and distributes a
broad range of innovative diagnostic products. We are dedicated to
developing and delivering better solutions that give answers with
speed, accuracy and simplicity that are redefining the
possibilities of life from discovery to diagnosis. Through
discovery and development, we provide critical life science raw
materials used in immunological and molecular tests for human,
animal, plant, and environmental applications. Through diagnosis,
we provide diagnostic solutions in areas including gastrointestinal
and upper respiratory infections and blood lead level
testing. We build relationships and provide solutions to
hospitals, reference laboratories, research centers, veterinary
testing centers, physician offices, diagnostics manufacturers, and
biotech companies in more than 70 countries around the world.
Meridian’s shares are traded on the NASDAQ
Global Select Market, symbol VIVO. Meridian’s website address
is www.meridianbioscience.com.
Contact:Jack KennyChief Executive
OfficerMeridian Bioscience, Inc.Phone: 513.271.3700Email:
mbi@meridianbioscience.com
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