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FDA clears third Panther Fusion assay

Dec. 6, 2017Hologic announced that it has received FDA 510(k) clearance for its Panther Fusion AdV/hMPV/RV assay running on the Panther Fusion system. The assay detects adenovirus, human metapneumovirus, and rhinovirus.

The Panther Fusion assays, which also include the Panther Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, offer a modular approach to syndromic respiratory testing via the ability to run one, two, or all three assays from a single patient specimen.

The Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems to extend testing capabilities. The module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the Company’s Aptima brand.

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