CINCINNATI--(BUSINESS WIRE)-- Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO - News), today announced that it has received clearance from the Therapeutic Goods Administration (TGA) for its illumigene Group B Streptococcus (GBS) test, the newest molecular product on the illumigene platform. The approval in Australia for the commercialization of illumigene GBS, comes on the heels of the recent FDA clearance in the United States.
illumigene GBS utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae from enriched cultures of women samples. The procedure is remarkably simple, highly sensitive and produces results in less than an hour, which can help in the early diagnosis and proper management of this preventable disease. Countries that have adopted a screening-based preventive measure for GBS infection have demonstrated a decrease in incidence of Early Onset GBS in newborns. Yet GBS continues to be a major prenatal pathogen and is associated with significant morbidity and mortality amongst infants. GBS screening test is performed by using a vaginal/rectal swab at 35 to 37 weeks of pregnancy.
Colin Denver, Regional Sales Director of Bioline Australia, commented, “We are looking forward to the opportunity to introduce illumigene GBS to the Australian market. This test provides our customers with a simple platform for highly accurate detection of GBS infection, which can help prevent serious disease in infants. With more than 250,000 births in Australia each year, the effects of this infection can be significant.”
Richard L. Eberly, Chief Commercial Officer of Meridian Bioscience, Inc., stated, “illumigene GBS is a key addition to the illumigene platform given the importance of early detection of GBS to prevent serious disease in infants. This new test begins the expansion of the illumigene platform and provides a molecular technology that is affordable, simple, and quick. Our technology continues to appeal to any size acute care laboratory that is seeking molecular amplification capability with no capital investment and the ultimate in simplicity and accuracy.”
ABOUT MERIDIAN BIOSCIENCE, INC.
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, 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.
For more information about Bioline, please visit www.bioline.com
For more information about Meridian Life Science, Inc., please visit www.meridianlifescience.com
For more information about Meridian Bioscience, Inc., please visit www.meridianbioscience.com
Richard L. Eberly, Chief Commercial Officer, firstname.lastname@example.org
Meridian Bioscience, Inc.
Richard L. Eberly, Chief Commercial Officer, 513-271-3700