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
YES Announces Leadership Transition as Rezwan Lateef Appointed Chief Executive Officer3.12.2025 21:24:00 EET | Press release
YES (Yield Engineering Systems), a leading provider of high-performance process solutions for the semiconductor Advanced Packaging market, today announced that Rezwan Lateef has been appointed Chief Executive Officer. Mr. Lateef previously served as President of YES and has been a key driver of the company’s significant growth, global expansion, and product innovation over the past several years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202200541/en/ Rezwan Lateef, CEO of YES. The transition marks a natural progression for the company as it surpasses a key revenue milestone and enters its next phase of scaling with top tier semiconductor and AI computing customers. Rama Alapati, who has served as CEO since 2021, will step into a consulting role to support Mr. Lateef during the transition period and ensure strong organizational continuity. “Rama has played an instrumental role in elevating YES from a promising techno
Doha Debates Examines How Entertainment Shapes Us Today3.12.2025 19:13:00 EET | Press release
Qatar Foundation’s Doha Debates continues its flagship debate series with a new episode that examines how modern entertainment shapes our attention, creativity, and everyday well-being. Moderated by Dareen Abughaida, the debate brings together three influential thinkers to ask whether today’s entertainment landscape is enriching us—or overwhelming us. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251203737439/en/ Doha Debates examines how entertainment shapes us today in a new episode, leading thinkers and students debate whether today’s entertainment elevates us or pulls us into distraction. (Photo: AETOSWire) This week’s debate features Marya Bangee, Senior Advisor at the Pop Culture Collaborative; Dr. Anna Lembke, Professor of Psychiatry at Stanford University and author of Dopamine Nation; and Nicholas Carr, Pulitzer Prize finalist and author of The Shallows. For Bangee, the power of entertainment lies in storytelling t
Vycellix Prepares for First-in-Human Study of Novel Allogeneic Cell Therapy Powered by Its Universal Cell Engineering Platform3.12.2025 19:00:00 EET | Press release
Vycellix, Inc., a biotechnology company developing next-generation allogeneic cell therapies designed to overcome the risk of immune rejection, today announced the successful completion of pre-clinical development for its universal cell engineering platform (VY-UC) with rigorous studies across many donor cell types proving robust immune evasion with functional persistence. The Company is now preparing for first-in-human clinical validation by seeking regulatory approval in Sweden to initiate a Phase 1 study for its lead VY-UC product candidate, a novel, off-the-shelf natural killer (NK) cell therapy (VNK-101) for patients with relapsed or refractory multiple myeloma. VY-UC is a single-step CD45 engager strategy intended to address a central barrier to donor-derived cell therapies, the host immune system’s rapid elimination of allogeneic cells. In pre-clinical studies, VY-UC expression enabled engineered donor cells to evade host cellular immune attack while retaining function, supporti
Pattern Announces Acquisition of ROI Hunter, Connecting Product-Level Advertising and Marketplace Performance for Global Brands3.12.2025 18:01:00 EET | Press release
Pattern Group Inc. (Nasdaq: PTRN), a leader in accelerating brands on global ecommerce marketplaces by leveraging proprietary technology and AI, today announced that it has acquired ROI Hunter a.s., a performance-driven retail media platform for brands and retailers. ROI Hunter integrates product, marketing, and merchandising data into a single source of truth, enabling margin-informed, SKU-level advertising decisions across major walled-garden platforms including Google, Meta, and Snap. The acquisition strengthens Pattern’s position as the world’s leading ecommerce accelerator and expands the company’s AI-driven advertising capabilities across Meta, Google and Snapchat. ROI Hunter brings a defensible, SKU-level data moat anchored in API integrations and more than $1.8B in media managed annually, enabling a uniquely granular view of product-level performance. “We are thrilled to welcome the ROI Hunter team to Pattern,” said Dave Wright, Co-founder and CEO of Pattern. “Their deep techni
DevvStream and Southern Energy Renewables Announce Business Combination Targeting Low-Cost Production of Carbon-Negative SAF and Green Methanol3.12.2025 16:40:00 EET | Press release
DevvStream Corp. (Nasdaq: DEVS) (“DevvStream”), a leading carbon management and environmental-asset monetization firm, and Southern Energy Renewables Inc. (“Southern”), a U.S.-based producer of low-cost fuels made from biomass, with a flagship Louisiana project that plans to utilize regional wood-waste biomass to deliver green methanol and carbon-negative sustainable aviation fuel (“SAF”) at scale, today announced that they have entered into a definitive agreement to combine under a new U.S.-domiciled, Nasdaq-listed company, following customary closing conditions. The new company plans to help aviation and maritime operators meet tightening global mandates from regulations such as ReFuelEU and organizations such as the International Maritime Organization (“IMO”) by creating a U.S.–built, integrated clean‑fuels platform anchored in Louisiana, using domestic feedstock and workforce to produce carbon‑negative SAF and green methanol at commercial scale. Operationally, the combined company
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