Oct. 12, 2017—Hologic has received 510(k) clearance from the FDA for its Panther Fusion Flu A/B/RSV assay for use on its Panther Fusion system.
The Panther Fusion is available as a full system or as a module that can be attached to existing Panther systems. The Panther Fusion is capable of running polymerase chain reaction assays in addition to tests based on transcription-mediated amplification.
“Hologic has long-standing expertise in flu extending back to the introduction of ProFlu+, the first FDA-cleared Flu A/B/RSV assay on the market in 2008,” Tom West, president of the Diagnostic Solutions Division, Hologic, said in a statement. “This expertise has translated to the development of a test with excellent performance, and that test is now available on our integrated platform, which fully automates all aspects of testing, from sample to result.”