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
Andersen Global udvider sin afrikanske platform med tilføjelsen af medlemsfirma i Namibia9.5.2026 02:35:00 CEST | Pressemeddelelse
Andersen Global udbygger sin tilstedeværelse i Afrika med tilføjelsen af Andersen in Namibia, da Windhoek Advisory & Taxation tager Andersen-brandet til sig og styrker sine forudsætninger for at betjene virksomheder med aktiviteter i et af det sydlige Afrikas dynamiske vækstmarkeder. Andersen in Namibia har været et samarbejdsfirma siden 2021 og er en lokalt ejet revisions- og konsulentvirksomhed, der leverer ydelser inden for regnskab, skat og forretningsrådgivning, tilpasset de unikke behov i Namibias erhvervsklima. Med ekspertise inden for minedrift, landbrug, logistik, turisme og finansielle tjenesteydelser – sektorer, der er afgørende for Namibias økonomi – bistår firmaet både indenlandske virksomheder og internationale selskaber, der etablerer sig i regionen. Gennem cloudbaseret teknologi og datadrevet indsigt leverer Andersen i Namibia effektive og skalerbare løsninger, der gør det muligt for virksomheder at optimere deres drift, håndtere skatteforpligtelser på tværs af jurisdik
Andersen Consulting styrker sine kompetencer inden for organisatorisk transformation med Afiniti8.5.2026 20:45:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Afiniti, et globalt konsulentfirma inden for forretningstransformation med hovedkontor i Storbritannien, der hjælper organisationer med at levere og opretholde komplekse forandringsprojekter. Afiniti blev stiftet i 2003 og er et globalt konsulenthus inden for forretningsforandring med base i Storbritannien og USA. De støtter klienter gennem komplekse transformationer på tværs af mennesker, processer, systemer og data, og de skaber mærkbare forandringer gennem kreative konsulentydelser. Virksomheden betjener primært stærkt regulerede, sikkerhedsdrevne og aktivtunge organisationer med store, geografisk spredte arbejdsstyrker inden for sektorer som energi, forsyning, biovidenskab, transport og byggeri. Afiniti samarbejder med velkendte brands om at levere ekspertise fra start til slut på tværs af organisatoriske, digitale og ai-baserede transformationer samt ændringer i kultur og driftsmodeller. Dette gælder især komplekse scenarier s
Verdantis Launches MRO360 “The World's First AI-Native Spare Parts Intelligence Platform”8.5.2026 15:40:00 CEST | Press release
MRO360 is the first milestone in Verdantis's journey to deliver the industry's first fully AI-native Enterprise Asset Management solution. Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time. Unlike traditional EAM and CMMS platforms built on static rules, MRO360's agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk
Cyble Positioned as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies8.5.2026 15:22:00 CEST | Press release
Cyble today announced it has been recognized as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies. The company believes this recognition underscores Cyble’s mission to make threat intelligence truly operational—delivering AI-native capabilities that enable enterprises, government agencies, and MSSPs to shift from reactive security to proactive, intelligence-driven defense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508164528/en/ Cyble Named a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies "Security teams are under constant pressure to respond faster with greater accuracy," said Beenu Arora, Co-Founder and CEO, Cyble. "We believe this recognition highlights our focus on delivering intelligence that drives real outcomes—cutting through noise, accelerating response, and enabling confident decision-making at scale." Intelligence That Acts
WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features8.5.2026 15:00:00 CEST | Press release
New updates introduce a more personalized, data-driven member experience—bridging the gap between continuous biometrics, real-world context, and clinical insight WHOOP, the human performance company, today announced a new suite of health and AI-driven enhancements and feature updates across the WHOOP memberships, marking a major step forward in its evolution into an intelligent health platform. These updates deepen the company’s commitment to delivering highly personalized, accurate, and actionable insights. They signal the company’s expansion beyond performance optimization into clinical-grade health support. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508464188/en/ WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features “WHOOP is a membership, and we take that seriously,” said Ed Baker, Chief Product Officer of WHOOP. “We’re always asking how we can deliver more value to our members, and the
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