www.fdanews.com/articles/184751-hologics-3rd-respiratory-assay-snags-fda-clearance
Hologic’s 3rd Respiratory Assay Snags FDA Clearance
December 11, 2017
The FDA cleared the third Hologic respiratory assay for use in its Panther Fusion system.
The AdV/hMPV/RV assay, featuring modular panels, is indicated for the detection of adenovirus, human metapneumovirus, and rhinovirus.
The other two respiratory assays that run in the Panther Fusion system — the Flu A/B/RSV assay and the Paraflu assay — received FDA clearance in October. The assays can perform multiple tests using a single sample.