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Hologic Receives 510(k) Clearance for AdV/hMPV/RV Assay on Panther Fusion System

NEW YORK (GenomeWeb) – Hologic said today that the US Food and Drug Administration has granted 510(k) clearance for its Panther Fusion AdV/hMPV/RV assay, a multiplexed test that runs on the firm's Panther Fusion system. 

The new test, the third respiratory assay available on the Panther Fusion system, detects adenovirus, human metapneumovirus, and rhinovirus, and it complements the Panther Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, both of which received clearance in October.

Tom West, president of the diagnostic solutions division at Hologic, said that the clearance and launch of the new assay completes the firm's initial set of modular assays for respiratory viruses.

Hologic said that some respiratory panels on the market require testing for 20 or more targets even when a physician has only requested three or four, which makes testing time-consuming and expensive for laboratories. The Panther Fusion assays 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 firm said.

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

Adenoviruses cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, and they can cause illnesses such as gastroenteritis, conjunctivitis, cystitis, and neurological disease. hMPV is a common respiratory pathogen, mostly experienced by infants and young children. The virus is associated with both upper and lower respiratory tract infections and may be a trigger for asthma. Rhinoviruses are the causative pathogens in more than half of viral respiratory infections, and they are associated with acute exacerbations of respiratory conditions, including asthma, sinusitis, otitis media, and chronic obstructive airway disease, Hologic said.