Bioline Receives Clearance from TGA for the Commercialization in Australia of the New Molecular Test illumigene® Group B Streptococcus

Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc.

, today announced that it has received clearance from the Therapeutic Goods Administration (

) 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.