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Quidel's antepartum diagnostic test gets US FDA clearance

The U.S. Food and Drug Administration granted 510(k) clearance to Quidel Corp.'s Solana GBS Assay test, which detects Group B streptococcus in women nearing childbirth.

The bacteria can cause infections leading to sepsis, pneumonia and meningitis in newborns. Deafness and developmental disabilities may also result from the transmission Group B streptococcus at delivery.