DiaSorin Molecular LLC, Cypress, Calif, recently announced that it has attained CE marking for its new SimplexaGroup B Strep Direct assay. Designed for use on the company’s Liaison MDx instrument, the highly sensitive assay enables the direct in vitrodetection 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 a fast and efficient workflow. The assay has also been submitted for FDA clearance under the agency’s premarket notification (510(k)) process.
GBS infection is a leading cause of early-onset neonatal sepsis. An estimated one in five pregnant women around the world carries GBS bacteria, which is a major, yet preventable, cause of maternal and infant infection globally. Vertical transmission of GBS to the newborn can result in an invasive infection known as early onset disease (EOD). Infants with EOD will present with fever, lethargy, sepsis, pneumonia and, more rarely, meningitis within the first 24 to 48 hours of life. The World Health Organization estimates that GBS causes an estimated 150,000 preventable stillbirths and infant deaths every year.
“With this CE-marked assay we are pleased to enter the women’s health market,” says Michelle Tabb, chief scientific officer at DiaSorin Molecular. “Our company is driven to help hospitals and clinical labs provide excellent patient care through high-quality molecular assays and we are proud to add GBS to the important disease areas we address.”
For further information, visit DiaSorin Molecular.
Featured image: The Liaison MDx analyzer by DiaSorin Molecular.