Hologic Inc, Marlborough, Mass, has received FDA premarket notification (510(k)) clearance for its Panther Fusion Paraflu assay, a multiplexed assay that runs on the company’s new Panther Fusion system.
The Fusion Paraflu assay detects and differentiates parainfluenza viruses 1, 2, 3, and 4. It is the second diagnostic assay available on the Panther Fusion system, complementing the Panther Fusion Flu A/B/RSV assay, which received clearance in early October.
Human parainfluenza viruses commonly cause respiratory illnesses in infants and young children. Most patients recover, but parainfluenza viruses can also cause more severe conditions, including croup and pneumonia. Four types of parainfluenza viruses circulate at different times of the year.1
“It’s important to identify the cause of any infection to make sound clinical decisions about treatment,” says Tom West, president of the diagnostic solutions division at Hologic. “Molecular diagnostic tests have become the gold standard for pathogen detection due to their sensitivity and specificity.”
In addition to the Panther Fusion Paraflu and Flu A/B/RSV assays, Hologic expects to offer a third multiplexed Panther Fusion assay for adenovirus, human metapneumovirus, and rhinovirus. Currently undergoing FDA review, that assay is not yet available for sale in the United States.
Once all three Panther Fusion assays are cleared, they will provide a modular approach to syndromic respiratory testing, offering caregivers the ability to run one, two, or all three assays from a single patient specimen. The Panther Fusion assays also utilize ready-to-use reagents, which offer up to 60-day on-board stability.
“Our modular approach will enable laboratories to conduct respiratory testing in an efficient and cost-effective manner,” says West. “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.”
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. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and stat capabilities.
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.
For more information, visit Hologic.
- Human parainfluenza viruses [online]. Atlanta: Centers for Disease Control and Prevention, 2017. Available at: cdc.gov/parainfluenza/index.html. Accessed November 27, 2017.