FDA clears Meridian illumigene GBS assay

13 December 2011 (Last Updated December 13th, 2011 18:30)

Meridian Bioscience has received US Food and Drug Administration (FDA ) clearance for a new molecular diagnostic test for Group B Streptococcus (GBS) on the illumigene platform.

Meridian Bioscience has received US Food and Drug Administration (FDA ) clearance for a new molecular diagnostic test for Group B Streptococcus (GBS) on the illumigene platform.

The illumigene GBS assay is based on a simple procedure that includes heat treatment, amplification and detection. It enables laboratories to abide by the US Centers for Disease Control and Prevention (CDC) recommendations, benefitting from a simplified workflow and greater sensitivity for early diagnosis and proper management.

The GBS test uses loop-mediated isothermal DNA amplification technology to detect Streptococcus agalactiae in enriched cultures of samples from women, and the results are read on the illumipro-10 instrument.

Donna Mayne, supervisor of the microbiology, serology and molecular laboratories at Sacred Heart Hospital in Pensacola, Florida, said that the simplified procedure for diagnosing GBS will allow it to report accurate, definitive results in less time than culture.

"illumigene GBS fully complies with the CDC guidelines for the detection of GBS and is the most sensitive test on the market. Broth enrichment plus illumigene GBS empowers my laboratory to provide the highest standard of care for my patients,'' Mayne said.

Meridian Bioscience CEO Richard Eberly said that the new GBS diagnosing test is an addition to the illumigene platform and offers 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.

The company hopes that the "point-of-care" simplicity of this technology, along with its cost efficiency, make this test suitable in early detection and proper management of this preventable disease.

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

The company's diagnostic products are used outside of the human body and are designed to improve patient well-being while reducing the total outcome costs of healthcare.