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FDA Clears Hologic Panther Fusion GBS Assay

NEW YORK (GenomeWeb) – Hologic today said that it has received clearance from the US Food and Drug Administration for its Group B Streptococcus (GBS) assay on the Panther Fusion system.

Tom West, president of the diagnostic solutions division at Hologic, said in a statement that 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. He noted that with the GBS assay clearance, the firm's products now extend to newborns. The assay has been CE marked for diagnostic use and is commercially available in Europe.

The assay runs on the firm's Panther Fusion module, which can be added to existing Panther systems to extend testing capabilities. Panther Fusion adds the capacity to run polymerase chain reaction assays to the transcription-mediated amplification assays that are performed on the base Panther system.

According to Hologic, clinical research has shown that its GBS assay exhibited 100 percent sensitivity compared to culture-based testing methods. The assay increases testing options for healthcare providers because it is validated for the two enrichment broths that make up 95 percent of the samples used on the market, and it has less stringent requirements for clinical sample storage and transport than culture-based tests, Hologic noted.

GBS, a bacterium carried by some women, can lead to serious health consequences for newborns and death from illnesses including meningitis, blood poisoning, or pneumonia if the bacterium is passed from a mother to her baby during labor. An estimated 18 percent of women in the US are carriers, making universal screening imperative so that perinatal transmission to the baby can be prevented, Hologic said, citing a journal of Clinical Infectious Diseases study.

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