New Assays Differentiate Between Multiple Respiratory Viruses with Similar Symptoms

Hologic, Inc. (Marlborough, MA, USA) is now offering its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and its Novodiag RESP-4 molecular diagnostic test for sale in the European Union in time for the northern hemisphere’s respiratory viral season. Both assays detect and differentiate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus (RSV) that can present with similar clinical symptoms.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that uses nasopharyngeal swab samples and runs on the fully automated high-throughput Panther Fusion system. The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access functionality to run laboratory developed tests.

The Novodiag RESP-4 assay uses nasopharyngeal swab samples and includes an embedded cellularity control to ensure that the sample was correctly taken. The Novodiag RESP-4 assay runs on the Novodiag system, a fully automated molecular diagnostic solution that delivers on-demand testing for infectious disease and antimicrobial resistance. The Novodiag system combines real-time PCR and microarray capabilities that enable multiple pathogens to be identified in a single sample, providing a simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing. It delivers clinically relevant results in central labs or tertiary settings and its rapid ‘sample-in, result-out’ system allows for the fully automated detection of novel coronavirus in approximately one hour. It can be used as the main molecular platform for emergency, decentralized, and out-of-hours testing, or in association with the Panther System.

“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,” said Jan Verstreken, Group President International. “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,” added Verstreken. “The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was developed and will be manufactured at our facility in San Diego, CA. 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.”

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