TGA clears Bioline's illumigene Group B Streptococcus test

Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), 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."