MA-HOLOGIC,-INC.
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
LambdaTest and SVAM International Inc. Announce Partnership to Transform Quality Engineering for Businesses26.11.2025 18:00:00 CET | Press release
The alliance empowers enterprises with accelerated SDLC cycles, reduced testing effort, and modern AI-driven digital transformation capabilities LambdaTest, a Gen-AI native quality engineering platform, announced a partnership with SVAM International, Inc., a global leader in digital transformation services. This strategic alliance marks a significant step forward in their mission to transform quality engineering for businesses worldwide. The partnership allows LambdaTest to extend its AI-native quality engineering capabilities into SVAM’s extensive digital transformation ecosystem. By integrating with SVAM’s experience in large-scale application development, testing, and delivery across major New York State and City agencies, as well as their platform expertise across Salesforce, ServiceNow, and Dynamics365, LambdaTest will empower more enterprises to modernize their software delivery pipelines. With LambdaTest’s intelligent test orchestration and execution engine at the core, teams c
GLORY Acquires Remaining Equity Shares in Acrelec Group26.11.2025 16:11:00 CET | Press release
Acrelec becomes a wholly owned subsidiary of Glory Glory Global Solutions (International) Ltd, a wholly-owned subsidiary of GLORY Ltd. [TYO:6457], has announced the acquisition of the remaining equity shares in Acrelec Group SAS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126039437/en/ Acrelec is a global technology company focused on reinventing the customer experience for restaurant and retail brands. Leveraging decades of software, hardware and service expertise, the company develops and integrates new platforms that increase customer engagement, optimize efficiency and improve operations. With over 120,000 installations across more than 70 countries, Acrelec counts many of the world’s best-known restaurant mega-brands among its customers. We announce that Jalel Souissi has left the Acrelec Group following the completion of the recent share acquisition. Jalel Souissi has played a pivotal role in the development and
Andersen Global styrker sin platform i Tyrkiet med tilføjelsen af medlemsvirksomhed26.11.2025 14:49:00 CET | Pressemeddelelse
Andersen Global udvider sin tilstedeværelse i Tyrkiet, efter at Celen Corporate Property Valuation & Counseling Inc. bliver til Andersen i Tyrkiet, hvilket udvider de kompetencer, der tilbydes under Andersen-brandet i landet. Det Istanbul-baserede firma blev stiftet i 1995 og ledes af Managing Partner Guniz Celen med en bred vifte af ydelser til både nationale og internationale kunder. Med ekspertise inden for finansiering af fast ejendom, værdiansættelse af materielle og immaterielle aktiver samt formueforvaltning leverer den tyrkiske afdeling af Andersen løsninger, der understøtter komplekse finansielle beslutninger for kunder i mere end 18 lande. “Vores mission har altid været at levere løsninger på de mest komplekse udfordringer inden for ejendoms- og investeringssektoren,” sagde Guniz. “At blive en del af Andersen-brandet styrker vores kompetencer som en betroet rådgiver og giver os adgang til globale ressourcer, hvilket gør os i stand til at skabe endnu større langsigtet værdi fo
Cegid Acquires Shine to Accelerate the Path of Becoming Europe's Leading Financial Copilot for SMBs and Accountants26.11.2025 14:00:00 CET | Press release
Transformative combination creates a powerhouse for SMBs and accountants, empowering businesses across Europe by integrating leading suites of e-invoicing, digital accounting, business accounts and payments, and HR solutions into a unified platform. Cegid, a European leader in cloud software for finance, accounting, HR, and retail software, and Shine, a fast-growing European fintech unicorn providing digital business accounts and payments, e-invoicing, accounting, and payroll software to small businesses across Europe, announced today that the companies have entered a definitive agreement to join forces to form a European champion and become a leading provider of software for businesses and their accountants. This transformational combination will create the first fully integrated, cloud-native and AI-driven financial hub for SMBs and accounting professionals in Europe – bringing together market-leading capabilities in e-invoicing, accounting, digital business accounts and payments, ta
U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma26.11.2025 12:00:00 CET | Press release
If approved, sonrotoclax will become the first BCL2 inhibitor for R/R MCL in the U.S., addressing a high unmet need in an aggressive cancerSonrotoclax previously received Breakthrough Therapy Designation based on clinically meaningful, rapid responses in R/R MCLBeOne Medicines will present the data supporting the NDA and Priority Review for the first time at ASH 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. “Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai Wang, Ph.D., Global Head of R&D at BeOne.
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