MA-HOLOGIC
5.3.2020 08:02:05 CET | Business Wire | Press release
A molecular assay for detecting the novel coronavirus SARS-CoV-2 (previously 2019-nCoV) on the automated Panther Fusion® system has been developed by investigators at Hannover Medical School in Germany, Hologic (Nasdaq: HOLX) announced today. The preclinical assay is described online in the Journal of Clinical Virology.1
The Open Access™ functionality on the Panther Fusion® system allows accredited medical laboratories to design and validate laboratory developed tests (LDTs) to run on the fully automated, high-throughput platform. Laboratories can run their LDTs simultaneously with commercially available CE-IVD assays in a random access model, without waiting to batch tests.
“Rapid diagnosis is critical to combatting the spread of pandemics, and the Panther Fusion system is well suited to this purpose,” said Albert Heim, M.D, head of molecular diagnostics at Hannover Medical School. “Using inactivated virus from cell cultures and commercially available control materials, we adapted two recently published PCR protocols2 to run on the Panther Fusion system. Our next step will be to validate our assay on clinical samples.”
The emerging SARS-coronavirus-2 (SARS-CoV-2) can cause severe respiratory tract infections (COVID-19) and has been declared a public health emergency by the WHO.3,4
“It’s extremely gratifying to see our instrument system being used to quickly develop a response to an urgent public health threat,” said Kevin Thornal, president of the Diagnostic Solutions division at Hologic. “We specifically designed Panther Fusion and Open Access functionality to give diagnostic lab customers maximum flexibility, both for their day-to-day needs and to respond quickly to emerging threats.”
Users of Open Access are required to follow all applicable local requirements for their laboratory and users in developing and validating their own LDTs on the Panther Fusion system.
The Panther system launched in Europe in 2010 and in the U.S. in 2012. The Panther Fusion module, which was launched in Europe in 2016, can be attached to existing Panther systems in the field to extend testing capabilities. Specifically, the Panther Fusion module adds the capacity to run PCR assays and the Open Access functionality allows labs to develop LDTs using the platform.
The assay described in this press release has not received CE-IVD certification in Europe or clearance from the Food and Drug Administration (FDA) in the United States.
About Hologic
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 these products will receive regulatory clearance in the United States or Europe, detect the SARS-coronavirus-2 effectively, meet potential demand, or achieve the benefits described herein. 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 release publicly 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, Panther, Panther Fusion, and Open Access are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.
References:
- https://www.sciencedirect.com/science/article/pii/S1386653220300470?viewFullText=true . Accessed March 4, 2020.
- V M Corman, O Landt, M Kaiser, R Molenkamp, A Meijer, D K Chu, T Bleicker, S Brunink, J Schneider, M L Schmidt, D G Mulders, B LHaagmans, B van der Veer, S van den Brink, L Wijsman, G Goderski, J L Romette, J Ellis, M Zambon, M Peiris, H Goossens, C Reusken, M P Koopmans, and C Drosten. 2020. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill, 25. DOI: 10.2807/1560-7917.ES.2020.25.3.2000045.
- N Zhu, D Zhang, W Wang, X Li, B Yang, J Song, et al. A Novel Coronavirus from Patients with Pneumonia in China. 2020. N Engl J Med. 382:727-733. DOI: 10.1056/NEJMoa2001017.
- T Ganzenmueller, R Kaiser, C Baier, M Wehrhane, B Hilfrich, J Witthuhn, et al. Comparison of the performance of the Panther Fusion respiratory virus panel to R-Gene and laboratory developed tests for diagnostic and hygiene screening specimens from the upper and lower respiratory tract. J Med Microbiol. (2020) In press. DOI 10.1099/jmm.0.001133.
SOURCE: Hologic, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200304005866/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
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 14:00:00 CEST | Press release
Non-arteritic anterior ischemic optic neuropathy (NAION) is a loss of blood flow to the optic nerve which causes spontaneous and rapid vision loss, for which there are currently no FDA-approved treatments. Given the substantial unmet need for effective treatments in NAION, in October 2025, Dompé was awarded a Commissioner’s National Priority Review Voucher (CNPV) by the US FDA to accelerate a potential Biologics License Application for intranasal nerve growth factor (NGF) in NAION. Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 202
CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 14:00:00 CEST | Press release
New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25%
Cover Genius Raises USD $100M Backed by Vista Credit Partners, Reaching USD $1.9 Billion Valuation as it Advances AI-First Platform and Global Expansion14.7.2026 14:00:00 CEST | Press release
Accelerating the AI roadmap and next era of embedded protection Cover Genius, the global infrastructure for embedded protection, today announced a USD $100M capital raise, backed by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on enterprise software. The raise values the business at USD $1.9 billion, advancing a new chapter for the company. Cover Genius operates a B2B2C embedded protection platform that connects 200+ partners with 50+ global insurance carriers to protect over 70 million end customers at the point of sale across travel, retail, ticketing and logistics. Unlike traditional insurers, Cover Genius dynamically adapts product design, pricing, and presentation in real time to match each merchant's unique customer journey and geography mix. “We’ve spent more than a decade building the trust layer the world’s largest digital companies rely on to protect their customers. Today’s raise is about broadening possibilities: movin
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 14:00:00 CEST | Press release
New Titles Expand on Landmark Work to Showcase How GIS Drives Better Decisions Across Water and Land Management Esri will debut the Power of Where Collection at the 2026 Esri User Conference. The collection builds on the 2024 book The Power of Where by Jack Dangermond, extending its ideas into real-world GIS applications. New titles in the collection highlight GIS uses in water forecasting, land records, infrastructure planning, and economic development. The series demonstrates how spatial analysis helps organizations address challenges including sustainability, climate resilience, and governance. Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world a
Esri Introduces ArcGIS for ServiceNow, Bringing Location Intelligence into Everyday Enterprise Workflows14.7.2026 14:00:00 CEST | Press release
New Integration Connects Platforms, Enabling Real-Time Mapping Directly Within Existing Systems Esri is launching ArcGIS for ServiceNow, an integration that connects ServiceNow, the AI control tower for business reinvention, with ArcGIS, bringing location intelligence into everyday enterprise workflows. The solution supports organizations across commercial, government, health care, utilities, energy, telecom, and other sectors. Users can visualize incidents, assets, work orders, facilities, and other business data on maps in real time within ServiceNow or ArcGIS, improving decision-making and operational efficiency. The integration eliminates data duplication by enabling seamless data sharing between systems, bridging business records with geographic context. ArcGIS for ServiceNow will debut in beta shortly after Esri User Conference. Esri, the global leader in geographic information system (GIS) technology, has announced ArcGIS for ServiceNow, connecting the two platforms for the firs
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