Hologic, Inc. has announced that it has received FDA clearance for its Group B Streptococcus (GBS) assay on the Panther Fusion® system.
GBS is a bacterium naturally carried by some women. If passed from a mother to her baby during labour, it can lead to serious health consequences for the newborn and even death from illnesses including meningitis, blood poisoning or pneumonia. The approval follows Group B Strep Awareness Month, the July initiative to promote awareness and prevention of GBS during pregnancy through early infancy.
If a pregnant woman carries the GBS bacterium – Streptococcus agalactiae – it can spread to the amniotic fluid after the onset of labor, ultimately transmitting to the baby during childbirth. While common and not harmful to healthy adults, the bacterium can cause serious health consequences or even death if passed to an infant. An estimated 18 percent of women in the U.S. are carriers, making universal screening imperative so that perinatal transmission to the baby can be prevented.
The new Panther Fusion GBS assay brings excellent performance and automation to detecting this bacterium. In fact, clinical research showed the Panther Fusion GBS assay exhibited 100 percent sensitivity compared to culture-based testing methods. The assay will also increase testing options for healthcare providers, as it is validated for the two enrichment broths that make up 95 percent of the samples used on the market. The assay also has less stringent requirements for clinical sample storage and transport than culture-based tests.
Tom West, president of the Diagnostic Solutions Division at Hologic said, “A nucleic acid amplification test is the most sensitive and reliable screening method available today for identifying pregnant women who are carriers of this serious bacterium. As a leader in diagnostics for women, our commitment to providing high quality, life-saving solutions now extends to newborns, who can be fatally impacted by GBS infection.”