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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Hologic Receives FDA Clearance for Paraflu Assay on Panther Fusion System

Hologic Receives FDA Clearance for Paraflu Assay on Panther Fusion System

Oct 26, 2017
|
staff reporter

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.

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