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
Global Beauty Market Grows 10% as AI and E-commerce Reshape Consumer Buying1.4.2026 03:00:00 CEST | Press release
Online sales outpace in-store by 6x as digital-first and AI-influenced commerce accelerates globally NielsenIQ (NYSE:NIQ), a global leader in consumer intelligence, today released its State of Beauty 2026 report, showing the global beauty market grew 10% year-on-year, with E-commerce expanding six times faster than in-store sales. The findings highlight a rapid shift to digital-first, AI-influenced commerce across key global markets. As consumer expectations evolve toward convenience, personalization, and seamless digital experiences, beauty brands are under increasing pressure to adapt. From AI-powered product discovery to social commerce and livestream shopping, the path to purchase is becoming more dynamic—requiring brands to move faster and engage consumers across an increasingly complex ecosystem. Key findings from the State of Beauty 2026 report: Global beauty sales grew 10% year-over-year, driven by strong digital acceleration E-commerce is growing 6x faster than in-store sales,
bet365 Partners with TestMu AI to Accelerate Global Release Velocity with Agentic AI Quality Engineering31.3.2026 19:01:00 CEST | Press release
Streamlines Hillside Technology testing across browsers and mobile devices while supporting rapid expansion into regulated markets. TestMu AI (Formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced that Hillside Technology Limited, the technology powerhouse behind global online gambling leader bet365, has adopted its platform to unify software testing and support hundreds of weekly production releases. The global online gaming industry is currently experiencing a massive shift, with the market projected to exceed $150 billion by 2030. As mobile gaming becomes the primary touchpoint for users, the technical complexity of delivering a seamless, low-latency experience has grown exponentially. For industry giants like bet365, the need to validate software across an infinite matrix of hardware, screen resolutions, and OS versions is a mission-critical requirement. This partnership ensures that, as gaming becomes more mobile-centric, bet36
IFF Secures First Heart Health Claim for Soy Protein in Australia and New Zealand31.3.2026 16:00:00 CEST | Press release
Regulatory milestone opens heart health growth opportunities for food and beverage manufacturers IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients and health & biosciences announced today that a new heart health claim for isolated soy protein has been accepted by the Food Standards Australia New Zealand (FSANZ). The approval enables food and beverage manufacturers in Australia and New Zealand to link soy protein consumption with healthy blood cholesterol levels. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330523416/en/ First heart health claim approved for soy protein in Australia and New Zealand. “For decades, IFF has invested in the science behind soy protein and its role in supporting cardiovascular health,” said Tony Andrew, vice president of protein solutions for IFF Food Ingredients. “This approved claim validates years of rigorous research and collaboration. With our deep expertise in ing
Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care31.3.2026 15:26:00 CEST | Press release
Sub-Q Bionics, a medical device company developing next-generation solutions to improve care for patients living with lymphedema, today announced the successful close of its $1.5 million pre-seed funding round. The round includes investment from Mayo Clinic and Yeda, the technology transfer company of the Weizmann Institute of Science, as well as several private investors. The Israel Innovation Authority also provided matching funds. The funding will enable Sub-Q Bionics to continue to develop its novel bionic lymph node technology designed to transform how lymphedema is managed, based on scientific innovations from the Weizmann Institute and Shamir Medical Center. The system aims to provide a solution to manage fluid with a subcutaneous implant that will allow patients freedom of movement, automatic fluid management and reduction of symptoms such as pain and swelling. Lymphedema affects millions of patients worldwide, especially breast cancer survivors, and remains significantly under
HTEC Achieves SOC 2 Type II Attestation, Reinforcing Commitment to Client Trust31.3.2026 15:25:00 CEST | Press release
HTECtoday announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331132225/en/ HTEC today announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. For clients, this means working with a technology partner whose practices are standardized, consistently executed, and independently verified over time. It reflects a level of operational maturity where security, reliability, and data protection are built into every engagement. Achieving this standard required coordinated effort across the entire organization. Compliance, engineering, delivery, security, IT, legal, and people t
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