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Medical Devices / Submissions and Approvals

Hologic’s 3rd Respiratory Assay Snags FDA Clearance

Dec. 12, 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.

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