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Panther Fusion GBS assay cleared

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October 2018—Hologic received FDA clearance for its group B Streptococcus assay on the Panther Fusion system. The Panther Fusion GBS assay is a real-time PCR assay for the qualitative detection of group B strep in antepartum women with dual-target detection of Cfb and SIP genes. The assay is compatible with vaginal-rectal swab samples enriched in Lim and Carrot broths. The company reported that the assay exhibited 100 percent sensitivity compared with culture-based testing methods.

Hologic, 508-263-2900


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