Hologic Inc, Marlborough, Mass, has received FDA premarket notification (510(k)) clearance for its Panther Fusion AdV/hMPV/RV assay, a multiplexed assay that runs on the company’s Panther Fusion system.
The new assay detects adenovirus, human metapneumovirus, and rhinovirus. It is the third diagnostic assay available on the Panther Fusion system, joining the Panther Fusion flu A/B/respiratory syncytial virus (RSV) assay and the Panther Fusion paraflu assay, which both received clearance in October 2017.
“Clearance and launch of the new Fusion AdV/hMPV/RV assay completes our initial set of modular assays for respiratory viruses,” says Tom West, president of the diagnostic solutions division at Hologic. “We now offer a suite of molecular assays that help labs maximize their efficiency when running respiratory tests, in addition to the benefits of doing so on the fully automated Panther Fusion system.”
The Panther Fusion assays 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 in the field to extend testing capabilities. Specifically, the Panther Fusion module adds the capacity to run polymerase chain reaction assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the company’s Aptima brand.
For more information, visit Hologic.