FDA approves Panther Fusion GBS assay as diagnostic for Group B Streptococcus infection.- Hologic.

Hologic announced that it has received FDA clearance for its Group B Streptococcus (GBS) assay on the Panther Fusion system. The new Panther Fusion GBS assay brings performance and automation to detecting this bacterium. 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.

The Panther Fusion module can be added to existing Panther systems to extend testing capabilities. The Panther Fusion system adds the capacity to run polymerase chain reactions assays to the transcription-mediated amplification assays that are performed on the base Panther system. As a result, labs will retain all the key benefits of the Panther platform – including full sample-to-result automation, the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time and STAT capabilities – while streamlining and refining specimen processing to maximize efficiency. The Panther Fusion GBS assay joins the Panther Fusion Flu A/B/RSV, Panther Fusion Paraflu, and Panther Fusion AdV/hMPV/RV assays, all of which received FDA clearance in 2017. The GBS assay has also been CE-marked for diagnostic use and is commercially available in Europe.