Meridian Gets FDA Clearance for New Neonatal Saliva CMV Test
来源: Nasdaq GlobeNewswire / 06 十二月 2018 07:30:01 America/New_York
CINCINNATI, Dec. 06, 2018 (GLOBE NEWSWIRE) -- 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.
Chief Executive Officer
Meridian Bioscience, Inc.