Hologic Announces Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV
Hologic, Inc. (Nasdaq: HOLX) announced today that it 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 four of the most prevalent respiratory viruses that can present with similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus (RSV).
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that runs on the fully automated high-throughput Panther Fusion system. The test uses nasopharyngeal swab samples.
The Novodiag RESP-4 assay runs on the Novodiag system, the fully automated molecular diagnostic solution that delivers on-demand testing for infectious disease and antimicrobial resistance. This test also uses nasopharyngeal swab samples and includes an embedded cellularity control to ensure that the sample was correctly taken.
Both products are compliant with the European In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC, and transition provisions for such devices included in the IVD Regulation (EU) 2017/746.
“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.”
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, 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.”
The launch of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay adds to the respiratory portfolio for the Panther Fusion system, which currently includes the Panther Fusion Flu A/B/RSV assay, the Panther Fusion Paraflu (Parainfluenza 1/2/3/4) assay, the Panther Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) and the Panther Fusion Bordetella assay.
The launch of the Novodiag RESP-4 assay further expands the Novodiag assay menu, which currently includes diagnostic assays for gastrointestinal infections, hospital acquired infections, antimicrobial resistance and respiratory infections.
For more information visit www.hologic.com.
About the Panther and Panther Fusion Systems
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 AccessTM functionality to run laboratory developed tests.
About the Novodiag System
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, decentralised, and out-of-hours testing, or in association with the Panther® System.
About Hologic, Inc.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Forward Looking Statements
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance that these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to publicly release any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.
Hologic, The Science of Sure, Mobidiag, Novodiag, Panther, Panther Fusion and associated logos are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.
SOURCE: Hologic, Inc.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220711005201/en/
Contact information
Investor Contact:
Ryan Simon
+1 858.410.8514
ryan.simon@hologic.com
Media Contact:
Jane Mazur
+1 508.263.8764
jane.mazur@hologic.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
PUMA Appoints Nadia Kokni as Vice President Global Brand Marketing8.1.2026 17:30:00 EET | Press release
Sports company PUMA has appointed Nadia Kokni as Vice President, Global Brand Marketing, effective January 1, 2026. Nadia joins PUMA’s global leadership team and reports directly to Chief Brand Officer Maria Valdes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108099913/en/ Sports company PUMA has appointed Nadia Kokni as Vice President, Global Brand Marketing, effective January 1, 2026. Nadia joins PUMA’s global leadership team and reports directly to Chief Brand Officer Maria Valdes. In her new role as PUMA’s most senior global marketing leader, Nadia will oversee brand marketing strategy, brand marketing creative direction, integrated marketing and communication globally. Her appointment comes as PUMA accelerates its global brand ambition and sharpens storytelling around its product icons and innovation pipeline. Nadia brings deep international experience shaping and transforming leading global brands across the spor
Xsolla Kicks Off Two Weeks of Industry Programming, Community Events, and Expanding Support for Global Developers Across the UK at the Industry’s Biggest Winter Event8.1.2026 17:00:00 EET | Press release
Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announces a comprehensive program of events and activations across the United Kingdom taking place from January 10 to 22, 2026. This coordinated programming schedule reflects Xsolla’s continued investment in the UK and European games ecosystem. Capitalizing on a pivotal moment in the global games calendar, Xsolla is bringing developers, partners, and creators together through partnerships, live events, thought leadership, and community building. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108943976/en/ (Graphic: Xsolla) “Pocket Gamer Connects London brings together one of the most diverse and forward-thinking communities in the mobile global games industry,” said Berkley Egenes, Chief Marketing and Growth Officer. “We’re here to build all the things for the video game industry by helping developers turn grea
Golub Capital Continues Strong Track Record of Consistent Results in 20258.1.2026 17:00:00 EET | Press release
Golub Capital delivered another year of “good boring,” consistent results for its stakeholders in 2025, aided by its commitment to specialization. “We have long believed that specialization is a key source of competitive advantage for Golub Capital,” said David Golub, President of the Firm. “The past year validated this. Our deep relationships, scale and expertise enabled us to continue delivering strong results for investors, sponsors, portfolio companies and our team despite a muted M&A environment and high levels of credit stress across the private equity ecosystem. We are grateful for our clients’ trust and remain committed to building long-term, win-win partnerships that endure through market cycles.” 2025 Highlights, based on preliminary results:1 Delivering strong credit performance, record fundraising and continued leadership in sponsor finance Closed $25+ billion in financing commitments in 2025 to support existing portfolio companies and new platforms across a broad range of
AMRA Medical Introduces AMRA® BCP Scan in the Netherlands Through a Strategic Partnership with Prescan, a National Preventative Health Leader8.1.2026 16:31:00 EET | Press release
AMRA Medical, the global leader in MRI-based fat distribution and muscle composition analytics, alongside Dutch preventative healthcare leader Prescan, are pleased to announce the official launch of our cutting-edge AMRA® BCP Scan service, powered by AMRA® Profiler (CE, NB 2862), in the Netherlands. The launch, which marks BCP Scan’s third new market entry of 2025 (Sweden & Germany), expands the availability of our service within the EU into the Netherlands through an exclusive partnership with Prescan, an independent health & wellness clinic in Baarn which specializes in preventive health screenings and care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108381985/en/ AMRA® BCP Scan available at Prescan AMRA’s CEO, Olof Dahlqvist Leinhard, stated, “This is another important step in bringing our mission of driving scientific breakthroughs into the clinic by enabling deeper understanding of health and disease through MRI-
Andersen Expands Capabilities with Addition of Scimitar8.1.2026 16:30:00 EET | Press release
Andersen Consulting enters into a Collaboration Agreement with Scimitar, a firm focused on accelerating innovation in the life sciences industry. Headquartered in the U.S., Scimitar, a premier strategy execution consulting firm for the life sciences industry, specializes in operating model design, digital transformation, and organizational change. The firm works with pharmaceutical and biotech companies to accelerate innovation, improve operational execution, and ensure compliance across the product lifecycle. Their hands-on, collaborative approach ensures solutions are not only fit for purpose but built to scale. “Life sciences companies are navigating a period of rapid scientific advancement, growing regulatory complexity, and increasing demand for operational agility while being held to the highest standards of patient safety and data integrity,” said Ramy Khalil, CEO of Scimitar. “By combining our deep industry knowledge with Andersen’s global reach and multidisciplinary capabiliti
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom