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FDA Approves New Test For Screening Infection In Babies

A new test that screens babies for the presence of a common infection was approved by the Food and Drug Administration on Tuesday. Group B streptococcus// is a common infection that is passed from mother to child. It can cause sepsis, pneumonia, meningitis, neurological damage or even death.

Although all women are tested for group B streptococcus during pregnancy, current screening methods can leave some babies at risk for contracting an infection from the bacterium. But the new test, which UF researchers studied for several months as part of a clinical trial, allows health-care workers to quickly screen mothers during labor, improving the odds that babies will receive preventive care so they will not be infected during delivery.

"Without any intervention, (group B strep) is the most common cause of early-onset infection in newborns," said Rodney Edwards, M.D., a UF assistant professor of obstetrics and gynecology in the College of Medicine who led the clinical trial at UF, one of six sites to study the test. "It can cause sepsis, meningitis and pneumonia. The likelihood of dying if you are a newborn is 5 percent. (With meningitis) even if the baby makes it through the infection there is a chance of cerebral palsy and cognitive delay."

The new group B strep test, developed by the California-based company Cepheid, allows doctors to screen for the bacterium during labor. Currently, women are screened for the organism a few weeks before birth because it takes a few days to receive results from the lab. But because some women do not contract the organism until after they are tested, some babies are still at risk for infection.

The first clinical molecular diagnostic test the FDA has approved, the technology can be adapted to detect other infections such as avian flu and even the deadly bug methicillin-resistant Staphylococcus aureus, Cepheid official say.

About one-quarter of women carry group B streptococcus i
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