Luminex Receives Clearance for its ARIES Streptococcus Assay for Pregnant Women

FDA cleared a group B streptococcus assay, developed by Luminex Corp. for use on its ARIES system, for detecting infection in pregnant women approaching childbirth.

The assay is a real-time polymerase chain reaction-based in vitro diagnostic test, designed to detect the bacteria’s nucleic acid from swab specimens. The Centers for Disease Control and Prevention recommends universal GBS testing of women in their 35th-37th week of pregnancy.

The clearance represents the third approved assay for use on the ARIES system, and the company expects to launch additional assays this year. The GBS assay has also received CE-IVD marking.