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
Social Development Bank Highlights Strategic Partnerships and Global Initiatives at DeveGo 202524.12.2025 18:27:00 EET | Press release
The Social Development Bank (SDB) hosted the second edition of the Entrepreneurship and Modern Business Practices Forum, “DeveGo 2025”, from 21 to 23 December in Riyadh. Held under the patronage of His Excellency Eng. Ahmed bin Sulaiman Al Rajhi, Minister of Human Resources and Social Development and Chairman of SDB’s Board of Directors, the forum brings together government leaders, global experts, investors, and entrepreneurs to shape the future of entrepreneurship and modern business practices in the Kingdom of Saudi Arabia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251224036724/en/ From right to left: Ahmed Al Rajhi, Saudi's Minister of Human Resources and Social Development, H.E. Rebeca Grynspan, Secretary-General of UNCTAD, and Sultan Al Hamidi, CEO of Social Development (Photo: AETOSWire) Opening the forum, Minister Al Rajhi delivered a keynote speech on the growing vibrancy of Saudi Arabia’s entrepreneurial movem
Making Science Unveils ‘AWAKE’: The AI Venture Studio Industrialising Startup Creation and AI-First Innovative Solutions23.12.2025 21:51:00 EET | Press release
Making Science, the global digital acceleration consultancy, today announced the launch of AWAKE Venture Studio. This "AI-first" model represents a new era in systematic innovation, designed to identify, prototype, and scale both internal proprietary solutions and independent AI-native startups with global reach. The launch of AWAKE is motivated by the significant efficiency gains of orders of magnitude that Making Science has already achieved through the internal integration of AI. By applying these methods, the firm has achieved a 2x acceleration in tech feature development reducing time in the deployment of AI Agents. This model has already proven its commercial and innovative power through the acceleration of startups like ad-machina, which has multiplied its value by 10 since joining the Making Science ecosystem. These proven benchmarks serve as the technical foundation for AWAKE’s two interconnected engines, which formalise this efficiency into a repeatable manufacturing process
FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia23.12.2025 19:07:00 EET | Press release
The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, a leader in eye health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the first and only Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia utilizing patented Extended Depth of Focus (EDOF) optical design technology, enabling commercial distribution in the United States. Deseyne® delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. This performance is enabled by Cataltheia’s patented hyper-refractive central zone, engineered to precisely redirect light in a controlled manner. The result is a clear clinical advantage over the only other available contact lens option for presbyopia, multifocal lenses, which rely on multiple optical zones and often require prolonged visual and cognitive adaptation. “We are proud to offer the first contact lens solution for the world’s aging population th
Aramco Awards SLB Long-Term Contract to Support Kingdom’s Unconventional Gas Production Growth23.12.2025 15:58:00 EET | Press release
Global technology company SLB (NYSE: SLB) has been awarded a five-year contract by Aramco to provide stimulation services for its unconventional gas fields. This award is part of a broader multi-billion contract, supporting one of the largest unconventional gas development programs globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251223074948/en/ The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources. The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources — a cornerstone of the Kingdom’s strategy to diversify its energy portfolio and support the global energy transition. “This agreement is an important step forward in Aramco’s effor
Tabelog, Japan's Largest (*1) Restaurant Search and Reservation Service, Launches Multilingual App for International Visitors23.12.2025 15:00:00 EET | Press release
Tabelog (https://tabelog.com/en/), Japan's largest restaurant search and reservation service operated by Kakaku.com, Inc., launched its multilingual smartphone application (iOS/Android) for international travelers on Monday, November 17, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251221963753/en/ The Tabelog Multilingual App for International Travelers — Japan's Largest Restaurant Search and Reservation Service With approximately 100 million monthly users(*3), Tabelog is Japan's premier service widely used by Japanese locals for daily restaurant discovery. Its database is unrivaled domestically, featuring information on approximately 890,000 establishments nationwide and over 85 million reviews and photos(*4). Unlike global map services or travel sites, Tabelog is built on "authentic ratings and reviews from local Japanese users," enabling travelers to discover truly exceptional restaurants beloved by locals — not
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