German Lab Demonstrates Feasibility to Detect SARS-Coronavirus-2 (SARS-CoV-2) Using Hologic’s Panther Fusion® System
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.
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.
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.
- 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.
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
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
Nike Extends its Athletic Leadership5.2.2020 19:00:00 CET | Press release
Today, NIKE, Inc. (NYSE: NKE), unveiled breakthrough innovation for athletes competing in the Tokyo 2020 Games, including footwear designed to provide runners with a measurable performance benefit for a new era of competition. The NEXT% platform, introduced by barrier-breaking marathoner Eliud Kipchoge, will now expand into new disciplines following its unparalleled success in distance running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200205005708/en/ An international group of athletes joined the Nike 2020 Forum in New York to unveil the brand's latest performance and sustainable innovations. From left to right: Ibtihaj Muhammad, English Gardner, Leticia Bufoni, Blake Leeper, Timothy Cheruiyot, Dina Asher-Smith, Tomoya Ochiai, Sky Brown, Chris Mosier, Nyjah Huston, DeAnna Price, Bebe Vio, Kevin Mayer, Megan Blunk, Brandi Chastain, Aaron Brown, Sophie Hahn, Aori Nishimura, Diana Taurasi, Miles Chamley-Watson, Leon Schae
Cepton Expands With $50 Million Investment From Koito5.2.2020 18:00:00 CET | Press release
Cepton Technologies, Inc., a leading provider of state-of-the-art, intelligent, lidar-based solutions, announced today that it has raised over $50 million in Series C funding. This brings Cepton’s total funding to nearly $100 million, providing a strong foundation to substantially ramp up its R&D efforts, expand its footprint in the automotive market and support major customers worldwide. The latest funding round was led by Koito Manufacturing Co., Ltd. (TYO:7276), the automotive Tier 1 and world-leading provider of automotive lighting systems, with an investment of $50 million. Existing investors in Cepton also participated in this round. As part of the transaction, Koito will obtain non-exclusive rights to manufacture and sell Cepton’s lidar sensor design for an automotive application, using key components supplied by Cepton. Cepton will use the proceeds to accelerate development and deployment of its advanced lidar technology in ADAS applications, in autonomous vehicle applications,
Imricor Announces First Cases Successfully Performed at Heart Center Dresden5.2.2020 17:40:00 CET | Press release
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) is pleased to announce the first procedures using the Company’s products following CE mark of the Vision-MR Ablation Catheter have been performed at the Heart Center Dresden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200205005672/en/ Drs. Christopher Piorkowski (left) and Thomas Gaspar (right) performing iCMR ablations at the Heart Center Dresden (Photo: Heart Center Dresden). Three procedures were successfully performed over two days by Dr. Christopher Piorkowski and Dr. Thomas Gaspar (https://www.herzzentrum-dresden.com/rhythmologie/unser-team/). Additional physicians at the Heart Center Dresden will also begin performing procedures immediately. These procedures mark the first iCMR ablations anywhere in the world to ever be performed outside of a clinical trial. They were performed in an iCMR lab fitted with a Siemens 1.5T MAGNETOM Aera MR scanner. “It’s ano
VALBIOTIS Announces a Global Strategic Partnership With NESTLÉ HEALTH SCIENCE For the Development and Commercialization of TOTUM-63, a Plant-derived Active Substance With Clinically Demonstrated Metabolic Health Benefits on Prediabetics5.2.2020 17:30:00 CET | Press release
Regulatory News: VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible ), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the signature of a global long-term strategic partnership with Nestlé Health Science for the development and commercialization of TOTUM-63, an innovative and patented combination of 5 plant extracts specifically designed to reduce the risk of developing Type 2 Diabetes on prediabetics. Sébastien PELTIER, CEO of VALBIOTIS states: “Nestlé Health Science is an ideal strategic partner for VALBIOTIS. Its global reach, strategic intent to develop science-based nutritional health solutions and focus on fighting metabolic disorders like diabetes will be instrumental to TOTUM-63's worldwide commercialization success. We are excited about the opportunity that this deal brings to VALBIOTIS and to the many millions of people around the world at risk of becoming Type 2 diabetics. This trans
Skilling lanserar branschens första sömlösa integration med Spotwares cTrader, inriktad på erfarna handlare.30.1.2020 08:00:00 CET | Press release
Forex- och CFD-handelsplattformen Skilling annonserade förra veckan lanseringen av branschens första sömlösa integration med Spotwares cTrader - en unik funktion som internt kallas Ett konto. Två plattformar. Detta pressmeddelande använder multimedia. Se den fullständiga versionen här: https://www.businesswire.com/news/home/20200130005070/sv/ Skilling lanserar branschens första sömlösa integration med Spotwares cTrader. (Photo: Business Wire) Funktionen gör att Skilling kan erbjuda sina kunder sömlös handel över två olika handelsplattformar på ett enda Skilling-konto utan att behöva finansiera och hantera två olika konton separat. ”Enkelt uttryckt ville vi ge våra kunder valet vilken handelsplattform de kan använda - vår egen Skilling Trader eller en mer avancerad klientorienterad cTrader. Problemet du har med andra mäklare som erbjuder flera plattformar är behovet av att finansiera två konton separat, upprätthålla sunda marginaler på två olika konton och också ha två uppsättningar av
inRiver utser Per-Olof Schroeder till ny VD29.1.2020 16:43:00 CET | Press release
inRiver, som levererar SaaS-baserade lösningar för Product Information Management (PIM), meddelar att styrelsen idag har utsett Per-Olof Schroeder till ny VD för bolaget. Per-Olof tillträder sin tjänst med omedelbar verkan. “Styrelsen tackar Thor Johnson för hans ledning av bolaget under de två senaste åren, och är glada över att välkomna Per-Olof som vår nye VD," säger inRivers styrelseordförande, Jorgen Smidt. "Per-Olof har en påvisad erfarenhet av att mycket framgångsrikt leda utveckling av SaaS Computing Services, molnbaserade tjänster, och samtidigt leverera stark tillväxt både gällande intäkter, lönsamhet och marknadsandelar. I sin roll som bolagets VD kommer han fortsätta att utveckla inRivers mission att hjälpa våra kunder bli bäst på att marknadsföra och sälja sina produkter." Schroeder har mer än 25 års erfarenhet av ledande befattningar inom IT-branchen, inklusive 15 år på Microsoft, varav sju år som chef över Microsofts Productivity & Business Process Business Group i väste
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