NEW YORK (GenomeWeb News) – Meridian Bioscience's wholly owned subsidiary Bioline announced today that its illumigene Group B Streptococcus test has received regulatory approval for commercialization in Australia.
Clearance from the Therapeutic Goods Administration follows similar action in the US by the Food and Drug Administration.
The test is based on loop-mediated isothermal DNA amplification technology and detects Streptococcus agalactiae from enriched cultures from vaginal swabs. Results can be achieved in less than an hour, Meridian said, adding that GBS remains a major prenatal pathogen and is associated with significant morbidity and mortality in infants.
"illumigene GBS is a key addition to the illumigene platform given the importance of early detection of GBS to prevent serious disease in infants," Richard Eberly, COO of Meridian, said in a statement. "This new test begins the expansion of the illumigene platform and provides a molecular technology that is affordable, simple, and quick."