Meridian Initiates Clinical Trials for New Neonatal Saliva CMV illumigene Test
CINCINNATI, Aug. 09, 2017 (GLOBE NEWSWIRE) — 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.