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
CMOs Face a ‘Reputation and Results’ Reckoning, According to NIQ’s 2026 Outlook19.11.2025 12:00:00 CET | Press release
Despite economic volatility, 83% of marketing leaders remain confident in their brands but cite ROI proof and data connectivity as top challenges, NIQ finds. NielsenIQ (NYSE: NIQ), a global leader in consumer intelligence, today released its CMO Outlook: Guide to 2026 report, revealing how chief marketing officers (CMOs) are navigating a critical inflection point between brand building and revenue accountability. According to the report, 83% of CMOs remain confident in their brand’s equity, even as they face tightening budgets and heightened scrutiny over ROI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118947080/en/ NIQ CMO Outlook: Guide to 2026 “Every marketing dollar is now under the microscope,” said Marta Cyhan-Bowles, Chief Communications Officer & Head of Global Marketing COE, NIQ. “With organizations prioritizing cost reductions, CMOs are being challenged not just to spend wisely, but to prove how marketing di
Data Space Technology Leaders Advance Data Interoperability in Construction and Real Estate at the Gaia-X Summit19.11.2025 11:03:00 CET | Press release
Leaders in data space technology are converging at the Gaia-X Summit, in Porto November 20-21, to address the imperative of interoperability within and across data spaces in the construction and real estate sectors. The main objective is to assess how data spaces can leverage the world’s estimated $393 trillion in real estate assets. Achieving this involves exploring numerous use cases among the entire building lifecycle, from design to demolition, including construction, renovation and facility management operations, which creates a win-win situation for both industry and technology stakeholders. In France, the construction and renovation market alone is estimated at €200 billion annually. Designed to address the sector’s challenges, Digital TER-X is a technology demonstrator serving the construction and real estate use cases. Its relevance has been recognized, notably by being named in November 2025 Gaia-X Lighthouse Project, just one year after its Gaia-X Endorsed Project status, an
Duco introduces agentic workspace; a new collaboration layer for intelligent operations19.11.2025 10:00:00 CET | Press release
Duco, the trusted control layer in an agentic world, today announced the launch of agentic workspace, a new capability within the Duco Platform designed to help operations teams work alongside intelligent agents with transparency, control and confidence. Agentic workspace is a collaboration environment where users can build, maintain, optimise, manage tasks and exceptions. All within a single, auditable workspace. It brings humans and autonomous agents together in a shared operational context, ensuring interoperability between systems while maintaining full oversight and explainability. “Agentic workspace is the next step in our mission to put people in control of automated operations,” said James Maxfield, Chief Product Officer at Duco. “As firms embrace agentic AI, they need tools that allow them to monitor, adjust and collaborate with these systems in real time. This workspace gives them that control, without slowing innovation.” By combining data automation, exception management an
Quectel Takes Smart Meters to the Next Generation at Enlit 202519.11.2025 10:00:00 CET | Press release
Quectel Wireless Solutions, an end-to-end global IoT solutions provider, has announced it is attending the Enlit 2025 event in Bilbao, Spain on 18-20 November 2025 and will be at Stand 1.G86. Quectel is attending to showcase how its comprehensive range of modules, antennas and services are poised to assist continued massive uptake of smart meters and assist industry moves from first to second-generation devices. With deployments of smart meters, comprised of electricity, water and gas meters, exceeding 1.06 billion at the end of 2023 and set to continue in all regions, according to IoT Analytics, Quectel is seeing growth across all meter types and expansion of meter-based use cases. Smart electricity meters are being deployed in developing markets for the first time and mature markets are accelerating deployments of second-generation smart meters to help users optimize consumption and manage their own power generation via two-way metering communications. Growth is being experienced acr
Pacsun Successfully Implements Manhattan Active® Point of Sale, Unifying Commerce and Cutting Checkout Times19.11.2025 09:00:00 CET | Press release
Manhattan Associates Inc. (NASDAQ: MANH) today announced that Pacsun, a leading youth fashion retailer, has successfully deployed Manhattan Active® Point of Sale (POS), a cloud-native in-store sales and service solution that empowers associates to merge digital convenience with personalised retailing. Following a five-month project start to pilot phase, Pacsun rolled out Manhattan's POS solution across 300 plus stores in just eight weeks. Mobile checkout capabilities eased long in-store lines, while unified inventory management, powered by RFID integration, supported seamless fulfilment across Instagram, Amazon, TikTok and Pacsun’s own channels. During peak holiday season, Pacsun achieved record breaking revenue and streamlined operations, with 40% of online orders being fulfilled via stores, optimising inventory proximity, labour capacity and shipping costs that reduced logistics expenses by 25%. Stores are now critical drivers of retail differentiation, with industry research showing
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