Luminex Corporation announced that it has received FDA clearance for the ARIES® Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the FDA has cleared for use on the Luminex ARIES Systems. The company has also achieved CE-IVD marking for the ARIES® GBS Assay. Infection with Group B Streptococcus (GBS), also known as Streptococcus agalactiae, is a leading cause of neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers. One in four pregnant women are colonized with GBS, with most not exhibiting symptoms; however, it can be transmitted to the newborn during delivery. If not treated, GBS can result in illness or even death in the first week of a newborn's life. The Centers for Disease Control and Prevention recommends universal GBS testing of women in their 35th-37th week of pregnancy. The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women. It offers higher sensitivity and increased accuracy when compared to culture, and a reduced turnaround time of two hours after enrichment, compared to 48 hours for culture, with simultaneous STAT and batch testing on the sample to answer ARIES® Systems.