MOBIDIAG
Mobidiag Ltd., a revenue generating, molecular diagnostics company with complementary platforms that address infectious diseases, antimicrobial resistance and other areas of unmet diagnostic need, today announces that it has received CE-IVD markings for its Novodiag® COVID-19 and Amplidiag® COVID-19 molecular diagnostic tests for the early detection of the SARS-CoV-2 virus, responsible for novel coronavirus infection (COVID-19).
These tests complement the Company’s already available antibody test, Anti-SARS-CoV-2 Rapid Test , that Mobidiag is distributing from its joint venture partner in China, Autobio Diagnostics. Mobidiag is now able to commercially offer a comprehensive diagnostic solution for novel coronavirus infections for hospital and lab based settings.
Due to the high demand for diagnostic devices and tests globally, Mobidiag has ensured that its supply chain and manufacturing capabilities are robust and able to support its customers. This includes, for example, the sourcing and acquisition of various consumables to cover the complete workflow from sample collection to the results (e.g. inhouse production of enzymes and the development of our proprietary mNAT™ Medium sample buffer and collection tubes).
Tuomas Tenkanen, CEO of Mobidiag, said, “With the CE-IVD mark approvals for our Novodiag COVID-19 and Amplidiag COVID-19 molecular diagnostic tests and our distribution of the Anti-SARS-CoV-2 Rapid antibody test, Mobidiag is now able to provide a complete diagnostic solution for the detection of COVID-19 infections across the life cycle of the virus.”
“Mobidiag has leveraged its existing technologies and expertise, including supply chain management and manufacturing, to ensure we are able to deliver a full range of diagnostic solutions to our customers.”
The Novodiag® COVID-19 and Amplidiag® COVID-19 molecular diagnostic tests are able to rapidly and reliably detect COVID-19 infections at an early stage in patients with signs and symptoms of respiratory infection. They have already earlier been granted emergency use authorisation in Finland, Sweden and France. The tests have been designed using dual targets of SARS-CoV-2 (orf1ab & N genes) to include at least one conserved region and one specific region to mitigate the effects of genetic drift and avoid cross-reaction with other endemic coronaviruses.
The Novodiag® COVID-19 assay allows qualitative determination of SARS-CoV-2 (orf1ab and N genes) directly from nasopharyngeal swabs. The test operates using the Novodiag® rapid ‘sample-in, result-out’ system, allowing the on demand fully automated detection of COVID-19 in approximately 1 hour. In addition, Novodiag® solution is a closed system which ensures the protection of laboratory staff and healthcare professionals from possible contamination. The user-friendly nature of the system means that the Novodiag® system can also be used in high risk and hard-to-reach areas and decentralized settings without the need for highly trained personnel.
The Amplidiag® COVID-19 assay complements the Novodiag® COVID-19 on demand test. Based on well-established high-throughput qualitative PCR technology, 48 samples can be processed in less than three hours while running on Mobidiag’s Amplidiag® Easy platform , which enables to clinicians an optimized sample screening process with automated DNA/RNA extraction and PCR plate setup.
In addition to these molecular tests, Mobidiag is distributing an antibody test allowing qualitative determination of Anti-SARS-CoV-2 (IgG and IgM antibodies of SARS-CoV-2) in human serum, plasma or whole blood in less than 15 minutes without any instrumentation. The Anti-SARS-CoV-2 Rapid Test is manufactured by Mobidiag’s joint venture partner in China, Autobio Diagnostics.
Please note that these tests are not home testing kits. They are only available for healthcare professionals, and not for patients directly. Please follow the recommended processes and guidance for your location if you believe you could be infected by SARS-CoV-2.
Notes to editors
About Mobidiag Ltd
Mobidiag is a commercial stage, fast growing molecular diagnostics company whose fast, cost-effective, widely applicable and robust technology makes the power of molecular diagnostics available to address the spread of infectious diseases and antimicrobial resistance (AMR) by rapid detection of pathogens and their potential resistance to antibiotics. Through its Amplidiag® and Novodiag® solutions, Mobidiag offers a comprehensive range of molecular diagnostic solutions for the detection of infectious diseases to laboratories of all sizes.
Mobidiag is headquartered in Espoo, Finland, with subsidiaries in France, UK and Sweden. To learn more, visit www.mobidiag.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200601005614/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
Zayed Sustainability Prize Honours Global Pioneers Advancing Progress14.1.2026 02:35:00 CET | Press release
US$5.9M awarded to 11 organisations and high schools from the UAE, Brazil, Canada, Nepal, Switzerland, Uganda and across six sustainability categories From AI-enabled diagnostics to Cooling-as-a-Service, this year’s winners deliver locally adapted innovations that empower millions In 18 years, the Prize has scaled solutions reaching more than 411 million people globally The Zayed Sustainability Prize, the UAE’s pioneering award for innovative solutions to global challenges, today announced the cohort of 2026 winners, celebrating 18 years of empowering communities and driving inclusive, sustainable progress around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113958706/en/ The 2026 winners of the Zayed Sustainability Prize were recognised by the President of the UAE in Abu Dhabi on 13 January 2026 (Photo: AETOSWire) In a ceremony held during Abu Dhabi Sustainability Week (ADSW) and attended by Heads of State, M
Alta Semper Secures USD 57.5 Million from EIB Group and IFC for Growth Fund II to Expand Healthcare Access Across Africa13.1.2026 19:30:00 CET | Press release
Alta Semper Capital LLP (“Alta Semper”), a London-based private equity firm focused on healthcare and consumer investments in high-growth markets, today announced that it has secured USD 57.5 million in commitments to Alta Semper Growth Fund II. These commitments come from a consortium of investors including the European Investment Bank (EIB) Group and the International Finance Corporation (IFC). This landmark partnership was signified earlier today with a momentous signing ceremony held at a Government Ministry in Cairo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113837616/en/ Andrew McDowell (EIB), Cheick Oumar Sylla (IFC), Gelsomina Vigliotti (EIB), Rania Al-Mashat (Minister of Planning, Economic Development and International Cooperation of Egypt), Bassel Rahmy (MSMEDA), Afsane Jetha (CEO, Alta Semper) and Mark Bryson-Richardson MBE (British Ambassador to Egypt) at the signing ceremony in Cairo. (Photo: AETOSWire)
500 Global and Creators HQ Support Creators and Founders Building Startups Collectively Valued at US$130M+13.1.2026 17:00:00 CET | Press release
500 Global, one of the world’s most active Silicon Valley-based venture capital firms1, and Creators HQ, the first content creator hub in the UAE and the Middle East enabling the creator ecosystem globally, announced the Creators Ventures Accelerator program is building and supporting creator-led startups collectively valued at over US$130 million.2 The Creators Ventures Accelerator received over 1,100 applications from content creators and technology startup founders across more than 70 countries. Following a competitive selection process, 21 creators and founders were chosen for the program. This cohort serves a community of 20M+ followers, subscribers, and users across platforms. “Creators represent a growing class of bona fide entrepreneurs, with 50 million creators globally, projected to grow at 10-20% annually over the next 5 years. The first iteration of this industry was built on visibility and virality to monetize. With consumers getting savvier and more discerning, we believe
Nexo Becomes First-Ever Title Partner of the U.S. ATP 500 Dallas Open in Multi-Year Deal13.1.2026 16:30:00 CET | Press release
The agreement builds on Nexo’s long-term approach to partnerships with established global sports institutions. Nexo, the digital assets wealth platform, has been named the U.S. ATP 500 Dallas Open’s first-ever Title Partner under a multi-year agreement beginning in 2026, as the company advances its long-term brand strategy through leading global sports properties. The partnership was unveiled in Dallas alongside the debut of the Nexo Dallas Open brand and the resurfacing of two public tennis courts in North Texas. As one of only two ATP 500 tournaments in the U.S. and the country’s sole indoor ATP Tour championship, the Dallas Open places Nexo among a limited group of ATP 500 title partners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113901822/en/ The Nexo Dallas Open “This partnership with Nexo represents a transformative milestone for the Dallas Open,” said Tournament Director Peter Lebedevs. “Securing a title spons
Blue Matter Establishes New Capabilities in Biopharma Research & Development Led by Partner, Tara Austraat-Churik13.1.2026 15:01:00 CET | Press release
Blue Matter is pleased to announce that it has established a practice area dedicated to serving clients in biopharmaceutical Research & Development (R&D). The practice is led by Tara Austraat-Churik, a Partner who joined the firm in September 2025. Tara Austraat-Churik has been serving life science clients for more than 20 years. Her areas of expertise include strategy development and implementation, operating model and organizational design, and process optimization in R&D and Medical Affairs. Prior to joining Blue Matter, she served as Managing Director in R&D, Health, Science, and Wellness at EY. She has a robust background in consulting, which also includes roles at Booz Allen Hamilton, Navitas, WPP, and IBM. She holds a BA and MA from the University of Notre Dame and an MSc in Translational Medicine from the University of Edinburgh. The R&D practice, according to Austraat-Churik, exists to help biopharma companies simplify and accelerate the pathway to market. She adds, “R&D organ
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