Cepheid’s Xpert Xpress Strep Test for Pregnant Women Gains CE Mark

Cepheid has received the CE mark for its Xpert Xpress GBS (Group B streptococcus) molecular diagnostic test for detection of the bacterium during labor or at the time of delivery to help decrease early-onset neonatal sepsis.

GBS is a common pathogen in pregnant women that can cause invasive infections in infants after birth, leading to higher rates of admissions to neonatal intensive care units.

Many local guidelines recommend universal antepartum screening for GBS to help decrease early-onset neonatal sepsis, but testing remains limited in some places leading to unnecessary use of antibiotics, the company said.

The molecular test can deliver results in 30 minutes compared to days needed for results of a culture-based test.