DiaSorin Molecular announces that the FDA has cleared its new Simplexa GBS Direct assay for diagnostic use on the LIAISON MDX instrument. The highly sensitive assay enables qualitative detection of Group B Streptococcus (GBS) nucleic acid from 18- to 24-hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women, the results of which can aid in determining colonization status. The new assay can replace traditional culture testing methods and features an efficient, fast workflow.

DiaSorin Molecular