The Therapeutic Goods Administration (TGA) in Australia has approved Bioline's illumigene Group B Streptococcus (GBS) test.
Bioline is a subsidiary of Meridian Bioscience, which manufactures diagnostic test kits, purified reagents and related products.
illumigene GBS utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae from cultures of women samples.
GBS screening test is performed by using a vaginal/rectal swab at 35 to 37 weeks of pregnancy.
Meridian Bioscience chief commercial officer Richard Eberly said illumigene GBS is an addition to the illumigene platform given the importance of early detection of GBS to prevent serious disease in infants.