Hologic has introduced two new respiratory assays, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Novodiag RESP-4 molecular diagnostic test, in the European Union (EU).
The two assays have been designed for the detection and differentiation of four respiratory viruses that can have similar clinical symptoms, namely influenza A (Flu A), influenza B (Flu B), SARS-CoV-2 and respiratory syncytial virus (RSV).
The company stated that these assays are compliant with the European In Vitro Diagnostic Medical Device Directive (IVDD) and are being made available in time for the respiratory viral season in the Northern Hemisphere.
The cartridge-based assay Panther Fusion SARS-CoV-2/Flu A/B/RSV uses nasopharyngeal swab samples and runs on the completely automated Panther Fusion system.
Hologic’s Panther Fusion system portfolio already includes the Panther Fusion Paraflu (Parainfluenza 1/2/3/4), Panther Fusion Bordetella, Panther Fusion flu A/B/RSV, and Panther Fusion AdV/hMPV/RV assays.
The new Novodiag RESP-4 assay comprises an embedded cellularity control for ensuring correct sample collection.
It also uses nasopharyngeal swab samples and runs on the company’s fully automated molecular Novodiag system, which offers on-demand testing for infectious disease and antimicrobial resistance.
Hologic Group international president Jan Verstreken said: “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.
“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, California.”
This adds to the company’s growing Panther Fusion assays menu, which includes Panther Fusion EBV and BKV. Both of these were designed and manufactured at its recently acquired facility in Liège, Belgium.
The company’s Novodiag assay menu includes diagnostic assays for respiratory, gastrointestinal, antimicrobial resistance and hospital-acquired infections.
In May, Hologic received US Food and Drug Administration (FDA) approval for its Aptima CMV Quant assay.