Meridian Bioscience Receives FDA Clearance for New Molecular Test: illumigene Group B Streptococcus

Meridian Bioscience, Inc., VIVO today announced that it has received FDA clearance for a new molecular diagnostic test for Group B Streptococcus 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.