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Meridian Bioscience Receives FDA Clearance For New Molecular Test: Illumigene® Group B Streptococcus

Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced that it has received FDA clearance for a new molecular diagnostic test for Group B Streptococcus (GBS) on the illumigene ® platform. This innovative test is a strong addition to the illumigene platform. Group B Streptococcus, or GBS, continues to be a major perinatal pathogen, for both mothers and their infants, and is associated with significant morbidity and mortality. The CDC recommendations for GBS, published in November of 2010, indicated that a universal culture-based screening method should be performed at 35 to 37 weeks of gestation. (MMWR Vol 59 NoRR-10) The illumigene GBS test allows laboratories to comply with the CDC recommendations while benefitting from a simplified workflow and greater sensitivity for early diagnosis and proper management. Donna Mayne, Supervisor of the Microbiology, Serology and Molecular Laboratories at Sacred Heart Hospital in Pensacola, Florida states, “ illumigene GBS fully complies with the CDC guidelines for the detection of Group B Streptococcus (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. The simplified procedure will allow my laboratory to report accurate, definitive results in less time than culture.”

The illumigene GBS test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae in enriched cultures of samples from women. The test procedure is remarkably simple, highly sensitive, and yields results in less than one hour. It requires no expensive capital equipment. The test relies upon a simple procedure that includes heat treatment, amplification and detection. The entire amplification is isothermal and results are read on the illumipro-10™ instrument. All reagents and disposables are contained in the test kit and can be stored at room temperature. Meridian believes that the “point-of-care” simplicity of this technology, along with its cost efficiency, make this innovative test ideal for helping in early diagnosis and proper management of this preventable disease, especially in those instances where there is a low level of the biological target.

Richard Eberly, Chief Commercial Officer stated, “ illumigene GBS is a key addition to the illumigene platform given the importance of early detection of GBS to prevent serious disease in infants. This 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.”

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