Hologic Rolls Out 2 COVID-19/Flu A/Flu B/RSV Tests in Europe

By Sam Brusco, Associate Editor | 07.12.22

Released on the automated Panther Fusion and Novodiag systems

Hologic has released its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Novodiag RESP-4 molecular diagnostic test in the EU. Both assays spot and differentiate four of the most prevalent respiratory viruses: SARS-CoV-2, Influenza A, Influenza B, and respiratory syntactical virus (RSV)
 
The Panther Fusion SARS-CoV-2/Flu A/B/RSV cartridge-based assay runs on Hologic’s automated, high-throughput Panther Fusion system and uses nasopharyngeal swabs. The Novodiag RESP-4 assay run on the Novodiag system, an automated molecular diagnostic platform for on-demand testing for infectious disease and antimicrobial resistance. The Novodiag test also uses nasopharyngeal swabs with embedded cellularity control to ensure the sample was properly taken.
 
“As we move into the next phase of COVID, it is important that we evolve our assays to support our customers with tests that enable them to differentiate between the multiple respiratory pathogens as easily as possible. The ability to accurately differentiate between respiratory viruses with similar symptoms is essential if physicians are to ensure optimized care for each patient,” Jan Verstreken, Hologic’s group president of international told the press. “Together, these two assays further build our international offering of molecular diagnostic scalable solutions that meet the growing needs of a broad range of customers, from single-patient rapid testing to population-level screening.”
 
He continued, “The RESP-4 assay, developed and manufactured in Espoo, Finland is the first new Novodiag assay to be launched since Hologic’s acquisition of Mobidiag in June 2021. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was developed and will be manufactured at our facility in San Diego, Calif. It adds to our quickly growing menu of Panther Fusion assays, including the Panther Fusion EBV and BKV assays designed and manufactured at our recently acquired facility in Liège, Belgium.”
 
Hologic gained CE mark clearance for the molecular assays Panther Fusion EBV (Epstein-Barr virus) Quant Assay and Panther Fusion BKV (BK virus) Quant Assay earlier this year.