Bioline illumigene GBS assay gets Australian clearance

22 March 2012 (Last Updated March 22nd, 2012 18:30)

Bioline, a wholly-owned subsidiary of Meridian Bioscience, has received clearance from the Therapeutic Goods Administration (TGA) to commercialise its illumigene Group B Streptococcus (GBS) test in Australia.

Bioline, a wholly-owned subsidiary of Meridian Bioscience, has received clearance from the Therapeutic Goods Administration (TGA) to commercialise its illumigene Group B Streptococcus (GBS) test in Australia.

Illumigene GBS assay employs loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae from enriched cultures of female samples.

The procedure is performed using a vaginal or rectal swab at 35 to 37 weeks of pregnancy and generates results in less than an hour, which can help in the early diagnosis and proper management of the preventable disease.

Bioline Australia Regional Sales director Colin Denver said the test provides customers with a simple platform for 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," Denver added.

Meridian Bioscience chief commercial officer Richard Eberly said the 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," Eberly added.

Meridian is a fully integrated life science company which manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies.