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Hologic Receives FDA Clearance for Paraflu Assay on Panther Fusion System

NEW YORK (GenomeWeb) – Hologic said today that the US Food and Drug Administration has granted 510(k) clearance for its Panther Fusion Paraflu multiplexed assay, which runs on the Panther Fusion system.

The Fusion Paraflu assay detects and differentiates parainfluenza viruses 1, 2, 3, and 4, which commonly cause respiratory illnesses in infants and young children. Although most patients recover, HPIVs can cause more severe conditions, including croup and pneumonia.

The Fusion Paraflu assay is the second diagnostic assay available on the Panther Fusion system and complements the Panther Fusion Flu A/B/RSV assay, which received clearance earlier in October, Hologic said.

The firm noted that a third multiplexed assay — the Panther Fusion AdV/hMPV/RV test for detection and differentiation of adenovirus, human metapneumovirus, and rhinovirus — is not currently available for sale in the US, but it is under review by the FDA with the objective of obtaining clearance in the future.

Tom West, president of the diagnostic solutions division at Hologic, said that the "availability of three panels focused on the most frequently ordered tests allows labs the flexibility to meet specific patient needs without running unnecessary tests."

Once all three assays are cleared in the US, they will offer a modular approach to syndromic respiratory testing by enabling users to run one, two, or three assays from a single patient specimen, Hologic said, adding that the Panther Fusion assays also employ ready-to-use reagents that offer up to 60-day on-board stability. 

Hologic noted that the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities, or it can be purchased as a full system. The Panther Fusion module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, a proprietary chemistry that underpins the firm's Aptima brand, Hologic said. 

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

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