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
Civil Air Patrol Expands Fleet With 15 New Cessna Aircraft to Support Lifesaving and Community Missions15.12.2025 18:00:00 EET | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, announced today that Civil Air Patrol (CAP), the world’s largest operator of Cessna aircraft, is strengthening its national mission capabilities with an order for 15 additional piston-engine aircraft, including seven Cessna Skyhawk 172 and eight Cessna Skylane 182 models scheduled for delivery throughout 2026. The order follows recent deliveries of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft, expanding CAP’s fleet to more than 500 Cessna aircraft nationwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215613573/en/ Delivery of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft joins CAP’s fleet of more than 500 Cessna aircraft nationwide. Cessna aircraft are designed and produced by Textron Aviation. “Civil Air Patrol’s missions demand aircraft that are reliable, versatile and ready to perform in critic
Winston & Strawn and Taylor Wessing UK to Combine, Creating a Premier Transatlantic Law Firm15.12.2025 17:52:00 EET | Press release
Winston & Strawn and Taylor Wessing’s UK-led business announced today their intention to combine, creating a premier transatlantic law firm that would operate under a new shared name, Winston Taylor. The combination responds to increasing client demand for seamlessly integrated US–UK–EU counsel for the businesses, people, and markets driving capital and innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215914957/en/ The combination once final will unite two international firms with more than 400 years of combined history, complementary strengths, and a common vision to meet clients’ evolving global needs. The combined firm will include more than 1,400 lawyers, establishing one of the largest transatlantic firms whose footprint is primarily in the United States, the United Kingdom, and Europe, and also in Latin America and the Middle East. Leveraging significant strength and scale in major litigation, critical tra
Despite Barriers, Financial Institutions are Clear About AI's Greatest Impact15.12.2025 17:32:00 EET | Press release
HTEC, a global AI-first provider of software and hardware design and engineering services, today released The State of AI in Financial Services & Insurance 2025, a first industry subset of its global research report in AI. This publication offers one of the clearest views to date into how financial institutions are adopting and scaling artificial intelligence. This industry-focused report analyzes insights from 250 C-suite leaders within financial services and insurance, drawn from HTEC’s broader global study of 1,529 C-suite executives—including CIOs, CTOs, CDOs, CPOs, CFOs, COOs, CEOs and CSOs—across Saudi Arabia, the UAE, the United Kingdom, the United States, Germany and Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215790717/en/ Executive Summary: The State of AI in Financial Services and Insurance 2025 The findings confirm a decisive shift in the industry: not a single respondent said AI is not a priority. L
Align Partners Sends Second Public Shareholder Letter to Coway, Urging Announcement of Revised Value-up Plan by January 30, 202615.12.2025 16:54:00 EET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Coway Co., Ltd. (“Coway”) since 2023 holding more than 4% of the Company’s outstanding shares through funds it manages or advises, announced that it has sent a second public shareholder letter to Coway’s Board of Directors. The letter calls for measures to address the company’s chronic undervaluation and enhance shareholder value. Align Partners has requested that Coway announce a revised corporate Value-up Plan reflecting these proposals by January 30, 2026. In the letter, Align Partners assessed Coway’s February 2025 plan as insufficient to address Coway’s persistent undervaluation and urged the Board to incorporate seven measures: (1) clear mid-to-long-term valuation and ROE targets with execution plans; (2) clarified and strengthened target capital structure policy; (3) updated shareholder return policy reflecting both the target capital structure policy and new dividend income tax separation regime; (4) en
Marathon Asset Management Provides Junior Capital Financing to EXALTA Group15.12.2025 16:00:00 EET | Press release
Marathon Asset Management (“Marathon”), a leading global credit manager with more than $24 billion of assets under management, is pleased to announce the closing of a junior capital financing to EXALTA Group (“EXALTA” or the “Company”), a portfolio company of Montagu. Marathon led the financing that supported the formation of EXALTA through the strategic merger of three Montagu-owned companies including Intech, Resolve Surgical Technologies, and Tyber Medical. The transaction marks one of many successful transactions for Marathon’s European Credit business in the healthcare sector, where the firm has a knowledge-based advantage with a dedicated Healthcare Finance business and specialized medical advisory board providing sector insight to middle market companies. EXALTA is a global leader in orthopaedic contract design and manufacturing for spine, trauma, extremities, sports medicine and enabling technology providing comprehensive solutions to OEMs within the medical technology industry
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