DiaSorin Molecular Attains CE Mark for SimplexaTM Group B Strep Direct Molecular Assay
Cypress, Calif. (October 18, 2018) – DiaSorin Molecular LLC announced today that it has attained CE marking for its new SimplexaTM Group B Strep Direct assay. Designed for use on the LIAISON® MDX instrument, the highly sensitive assay enables the direct in vitro detection of Group B Streptococcus (GBS DNA). GBS infection is a significant challenge in the health management of women and newborns. The new assay is more specific than traditional testing methods and features an efficient, fast workflow. This assay has also been submitted to the FDA under their Premarket Notification process, to obtain 510(k) clearance.