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Hologic Receives FDA Clearance for Flu A/B/RSV Assay on Panther Fusion System

NEW YORK (GenomeWeb) – Hologic said on Thursday that the US Food and Drug Administration has granted 510(k) clearance for its Panther Fusion Flu A/B/RSV assay running on the Panther Fusion system. 

The firm said that Panther Fusion is available as a full system or, alternatively, as a module that can be attached to existing Panther systems to extend testing capabilities. Panther Fusion adds the capacity to run assays based on PCR in addition to those based on transcription-mediated amplification, the proprietary chemistry behind the firm's Aptima brand, the firm noted.

Hologic said that the Panther Fusion system provides full sample-to-result automation; the ability to run multiple tests from a single sample; random-access sample processing; continuous loading; and STAT capabilities. In eight hours, the system runs up to 335 Panther Fusion tests, or up to 500 Fusion and Aptima tests, and its assays employ ready-to-use reagents, which offer up to 60-day, on-board stability, the firm added. 

The FDA is reviewing Hologic's application for clearance of two other Panther Fusion respiratory panels — the Paraflu and AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) assays. 

Hologic said that clearance of the three respiratory assays would enable a modular approach to testing. Clinicians could run one, two, or all three assays from a single patient specimen.

Hologic's Diagnostic Solutions Division President Tom West said in a statement that consolidating testing "remains a key focus of our clinical laboratory customers." He said that offering multiple chemistries on a single platform expands menu while allowing labs to meet efficiency goals.

"By offering three smaller panels focused on the tests most frequently requested, we will offer labs maximum flexibility to design test runs to meet specific needs," West said.

He noted that the company has heard that many panels in the market are too large, and users must run up to 20 or more targets "when perhaps a physician has only requested three or four. Not only is this time-consuming for the lab, it is also not cost-effective."

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.