Hologic Gains Approval for Group B Strep Assay

The FDA granted approval for Hologic’s group B streptococcus (GBS) assay for its Panther Fusion system.

The approval comes after July’s GBS awareness month, an initiative to improve knowledge and prevention methods for GBS during pregnancy.

The nucleic acid amplification test is used to identify pregnant women that carry the bacterium, which can lead to life-threatening complications in their children.