Oct. 30, 2017—Hologic has received 510(k) clearance from the FDA for its Panther Fusion Paraflu assay, a multiplexed assay that runs on the 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 earlier this month.
A third multiplexed assay, the Panther Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) assay, is under review by the FDA and is not currently available for sale in the United States.
Once all three assays are cleared, 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 also utilize ready-to-use reagents, which offer up to 60-day onboard stability.
“Our modular approach will enable laboratories to conduct respiratory testing in an efficient and cost-effective manner,” Tom West, president of Hologic’s Diagnostic Solutions Division, said in a statement. “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.”