DiaSorin announced to have received FDA clearance for its new Simplexa Group B Strep Direct recently launched in the European market. Designed for use on the LIAISON MDX instrument, the new test enables the direct detection of Group B Streptococcus DNA.
The new assay can replace traditional culture testing methods and features an efficient and fast workflow. GBS infection is a leading cause of early-onset neonatal sepsis. An estimated one in five pregnant women around the world carries GBS bacteria and its vertical transmission 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.
“After the launch few weeks ago in Europe, now the Simplexa Group B Strep Direct is available also in the United States.” said Michelle Tabb, Chief Scientific Officer at DiaSorin Molecular LLC. “Our Group continue to support hospitals and clinical labs worldwide to provide excellent patient care through high-quality molecular assays also in the women’s health testing market all over the world.”
For more info: http://www.diasorin.com/sites/default/files/allegati_pressrel/pr_diasorin_gbs_eng.pdf