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Hologic Inc passes US FDA's 510(k) clearance for Panther Fusion Paraflu assay for Parainfluenza viruses 1, 2, 3 and 4.

M2 EQUITYBITES-October 27, 2017-Hologic Inc passes US FDA's 510(k) clearance for Panther Fusion Paraflu assay for Parainfluenza viruses 1, 2, 3 and 4


Medical company Hologic Inc (Nasdaq:HOLX) disclosed on Thursday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance for its Panther Fusion Paraflu assay that detects and differentiates Parainfluenza viruses 1, 2, 3 and 4.

The company stated the Panther Fusion Paraflu assay is a multiplexed assay that runs on the new Panther Fusion system. The Fusion Paraflu assay, which detects and differentiates Parainfluenza viruses, is the second diagnostic assay available on the Panther Fusion system, complementing the Panther Fusion Flu A/B/RSV assay.

In conjunction, the company's third multiplexed assay, the Panther Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) assay, is under review by the US FDA. Upon clearance of all three Panther Fusion assays, they will 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 assays utilise ready-to-use reagents, which offer up to 60-day on-board stability.

According to the company, the Panther Fusion is available as a full system or module that can be attached to existing Panther systems to extend testing capabilities. Specifically, the Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers its Aptima brand.

Additionally, the Panther Fusion system and Panther Fusion Flu A/B/RSV, Paraflu, and AdV/hMPV/RV assays have been CE-marked for diagnostic use and are commercially available in Europe, concluded the company.

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Publication:M2 EquityBites (EQB)
Date:Oct 27, 2017
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