Hologic Announces Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV
11.7.2022 15:00:00 EEST | 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.
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
Swedish Court Further Reschedules Delivery of Judgment in PriceRunner Vs Google Antitrust Case24.6.2026 21:55:00 EEST | Press release
Klarna Group plc (NYSE: KLAR) wishes to update investors that the Patent and Market Court in Stockholm, Sweden (Patent- och marknadsdomstolen) has again postponed publication of its judgment in the antitrust damages proceedings brought by PriceRunner, a Klarna subsidiary, against Google. The Court has rescheduled publication of its judgment from June 26, 2026 to July 1, 2026 at 13:00 CET. As with the Court's two previous notifications, the rescheduling is a procedural decision by the Court and relates solely to the timing of the judgment delivery. In its notification, the Court cited high workload as the reason for needing additional time to finalize the judgment. No inference about the outcome should be drawn from it. Important Notice The outcome of the proceedings is inherently uncertain. No assurance can be given that PriceRunner will succeed on liability or quantum. Any award would be subject to appeal by Google, to sharing arrangements with former PriceRunner shareholders and Klar
Vertex Energy Announces 6,000 bpd Group III Base Oil Expansion Project24.6.2026 17:00:00 EEST | Press release
Vertex Energy, Inc. (“Vertex” or the “Company”) today announced it is advancing a project at its Mobile, Alabama refinery to produce crude-derived conventional Group III base oils through the Company’s existing hydrocracker and related processing infrastructure, providing lubricant manufacturers and blenders with an additional domestic source of high-quality Group III supply. The project is designed to add an incremental 6,000 barrels per day of conventional Group III production capacity and support production of 4 cSt, 6 cSt, and 8 cSt Group III base oils using an existing crude-derived hydrocracked vacuum gas oil stream produced at the Company’s Mobile, Alabama refinery. Combined with the Company’s existing re-refined Group III base oil production, this additional capacity is expected to make Vertex the leading Group III producer in North America. Vertex has completed preliminary design work and has procured a high-pressure lubricants hydrotreating unit. The Company plans to start pr
Taktile Secures $110M in Goldman Sachs-led Series C to Power AI Transformation in Financial Institutions24.6.2026 16:30:00 EEST | Press release
Taktile, the leader in AI transformation for financial institutions, today announced its $110 million Series C fundraise. Growth Equity at Goldman Sachs Alternatives led the round, with participation from Balderton Capital, Index Ventures, Tiger Global, Y Combinator, and Dig Ventures. Taktile Fast Facts Taktile enables banks and insurers to transform into AI-native organizations that are increasingly powered by autonomous agents. Demand for Taktile accelerated in 2025, as AI models became capable of automating high-stakes decisions that previously required hours of manual work—from underwriting business loans and assessing claims to catching financial crime. Customers automate and optimize decisions with Taktile by combining its financial services expertise and product built for sector-specific AI use cases. One of the world’s largest insurers is running multiple use cases on Taktile, with projected cost efficiencies of over $90M in claims processing alone. Taktile’s team has a proven
New MetLife Study Reveals a 72% “Confidence Gap” in Ability to Recover from Life's Setbacks24.6.2026 16:25:00 EEST | Press release
A new multinational study from MetLife reveals a striking “confidence gap”: while most adults describe themselves as resilient, their confidence drops by 72% when faced with real-life setbacks. The Confident Pathways Report, conducted across the United States, United Kingdom, Japan, and Mexico, was designed to better understand how confidence is built and sustained throughout life. The findings underscore the role of opportunity, preparedness, and support in building confidence - factors that help people navigate uncertainty, recover from setbacks and pursue their goals. At a time when soccer is bringing people and communities together around the world, the findings also highlight how early childhood experiences such as sports, education, and mentorship can help foster resilience and gain confidence from a young age. Key findings across the four countries surveyed include: Confidence drops by 72% when adults consider their ability to recover from setbacks. Respondents were far more lik
StatLab Launches CytoPath Disc, Advancing Standardized Cell Block Preparation Worldwide24.6.2026 16:08:00 EEST | Press release
StatLab Medical Products, a leading global developer and manufacturer of pathology supplies and equipment, today announced the global launch of the CytoPath Disc, an innovative cell block preparation technology designed to standardize and simplify cell block preparation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624368623/en/ Developed as an alternative to traditional cell block methods, which convert concentrated cells suspended in fluid into a paraffin-embedded format for slide-based evaluation, the patent‑pending CytoPath Disc offers a more streamlined and efficient approach. The CytoPath Disc absorbs concentrated cells within a simple, sponge-like matrix, which is then processed, embedded, stained, and sectioned using standard histology workflows. Traditional cell block preparation methods often present challenges in achieving consistent results due to complex procedures, as well as the need for additional equipm
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