MA-HOLOGIC,-INC.
11.7.2022 14:02:06 CEST | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220711005201/en/
Link:
Social Media:
About Business Wire
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
Reply Launches Model Factory, the Production Line for Creating Industrial-Grade Generative AI Models14.5.2026 10:00:00 CEST | Press release
Reply [EXM, STAR: REY] announces Reply Model Factory, an industrial production line for buildingfrontier generative AI modelsgrounded in corporate knowledge and designed to power AI systems and agents aligned with each organisation’s operational context. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514524231/en/ Reply Model Factory is an industrial production line for building frontier generative AI models grounded in corporate knowledge and designed to power AI systems and agents aligned with each organisation’s operational context. AI models are often built to operate across a wide range of tasks, drawing largely on public data. Enterprises, however, rely on internal knowledge: technical standards, regulatory requirements, operating procedures, proprietary systems and domain expertise. Reply Model Factory addresses this gap by enabling organisations to train models that understand their own context and operate consist
Stitch Raises $25M Series A Led by Andreessen Horowitz14.5.2026 09:00:00 CEST | Press release
In a16z’s first investment in the GCC, the Riyadh-based fintech positions itself as the unified infrastructure layer for financial institutions worldwide Stitch, the operating system built for modern financial institutions, today announced it has raised $25 million in Series A funding led by Andreessen Horowitz (a16z). The investment marks a16z’s first in the GCC and brings Stitch’s total funding to $35 million. In addition to a16z, existing investors Arbor Ventures, COTU Ventures, Raed Ventures, and SVC also participated in the round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514070694/en/ Mohamed Oueida - Founder & CEO, Stitch (Photo: AETOSWire) Despite spending over $1 trillion on digital transformation in the last three years, most financial institutions are still running on the same fragmented, legacy infrastructure that has defined the sector for decades. Globally, banks spend $700 billion a year on technology
Corona Global Named Most Valuable Beer Brand in Kantar BrandZ Rankings for Third Consecutive Year14.5.2026 06:01:00 CEST | Press release
AB InBev Holds 8 of the Top 10 Most Valuable Beer Brands Globally Corona global has been recognized as the most valuable beer brand in the world for the third consecutive year in Kantar's BrandZ 2026 Most Valuable Global Brands report, released today. Eight out of the top ten most valuable global beer brands belong to AB InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD), according to the report ranking the best brands in the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513211378/en/ In 2025, Corona led AB InBev’s performance, increasing revenue by 8.3% outside of its home market with double-digit volume growth in 30 markets, while Corona Cero delivered strong double-digit volume growth. As the brand celebrated its 100th anniversary, Corona launched its global “Corona 100” platform, including a multi-year sponsorship of a renowned concert at Copacabana Beach in Rio de Janeiro. Strong momentum continued in Q1 2026
The Bolivarian Republic of Venezuela Announces the Initiation of a Comprehensive Public Debt Restructuring Process13.5.2026 22:08:00 CEST | Press release
The Bolivarian Republic of Venezuela announces today its decision to initiate a comprehensive restructuring of its external public debt obligations. CONTEXT & RATIONALE Over the past decade, Venezuela's economy has been severely impacted by external shocks – from the end of the commodity super-cycle to foreign sanctions and COVID-19 – resulting in a sharp economic contraction, a protracted default since 2017, and a ballooning of public sector liabilities. The country nonetheless possesses a strong economic potential, including unique hydrocarbon and mineral endowments. A recovery is underway, and Venezuela is committed to accelerating it through a comprehensive reform agenda in support of growth, fiscal sustainability, monetary stabilization, and enhanced governance. Restoring public debt sustainability is central to this agenda: the current debt overhang constrains external financing, limits public investment capacity, and prevents full re-engagement with the international financial s
Boomi Announces Intent to Acquire Lunar.dev to Deliver Governed Agent Connectivity Across the Enterprise13.5.2026 21:00:00 CEST | Press release
Proposed acquisition extends Boomi’s AI gateway capabilities, enabling enterprises to govern massive volumes of traffic for production-ready AI Boomi, the data activation company for AI, today announced it has signed a letter of intent to acquire Lunar.dev, an innovator in AI and MCP gateway. The proposed acquisition is expected to enrich the Boomi Enterprise Platform and Boomi Connect with advanced capabilities to govern and scale AI usage across enterprise systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513850557/en/ Boomi Announces Intent to Acquire Lunar.dev to Deliver Governed Agent Connectivity Across the Enterprise As organizations move from AI experimentation to production, controlling how agents and AI applications interact with LLMs at scale has become critical. Lunar.dev addresses this need with an AI gateway that delivers granular, policy-driven control over AI interactions, with the visibility, securi
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