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
Binarly to Unveil “Broken Trust” Research: Firmware Bypass Chains, BMC Persistence, and EDR Evasion15.1.2026 23:04:00 CET | Press release
Binarly, the industry leader in software and firmware supply-chain security, today announced an upcoming DistrictCon presentation “Broken Trust: Firmware Bypass Chains, BMC Persistence, and EDR Evasion.” The session will detail how firmware-level attack chains observed in shipped enterprise devices can effectively undermine modern endpoint defenses, enabling stealthy compromise and long-lived persistence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115834965/en/ Binarly Unveils Broken Trust Research: Firmware Bypass, BMC Persistence In this presentation, the Binarly REsearch team will dismantle the assumption of hardware trust by presenting multiple real-world firmware bypass chains. Alex Matrosov and Fabio Pagani will provide a deep dive into the specific vulnerability classes and exploitation primitives that make these attacks reliable in practice. The team will also deliver a live demonstration compromising a fully
Coolbrook Named on the 2026 Global Cleantech 10015.1.2026 18:14:00 CET | Press release
Coolbrook, a transformational technology and engineering company on a mission to decarbonise major industrial sectors like petrochemicals and chemicals, iron and steel, aluminium, and cement, has been named on Cleantech Group’s 2026 Global Cleantech 100. This annual list recognizes companies poised to deliver market-ready solutions that advance a cleaner, more resilient global future. The report highlights innovators addressing some of the world’s most urgent environmental and infrastructure challenges. The complimentary report introduces you to innovators advancing groundbreaking technologies and business models to enable us to act on the ever-increasing climate and environmental crisis. Following a 2025 marked by geopolitical volatility and shifting economic signals, the global cleantech ecosystem enters 2026 with slightly greater certainty - yet heightened competitive pressure. Growth is concentrating around two dominant themes: AI infrastructure and critical minerals. “The 2026 Glo
World Economic Forum and Salesforce Empower Global Leaders With First-of-its-Kind Agentic Assistant for the 2026 Annual Meeting in Davos15.1.2026 18:01:00 CET | Press release
The Forum activates its vast data stores through Agentforce 360, enabling a level of preparation and decision-making for its over 3,000 attendees previously unachievable by human processing alone Salesforce (NYSE: CRM), the world’s #1 CRM, today announced the activation of the World Economic Forum’s institutional knowledge powered by Agentforce 360 to support over 3,000 of the world’s most influential leaders at the 2026 World Economic Forum Annual Meeting. The Forum has launched a new proactive, high-precision concierge app, “EVA,” built on the Agentforce 360 Platform, Salesforce’s agentic platform. EVA will empower attendees to move beyond traditional information access, with an AI agent that doesn’t just answer questions, but can reason, prioritize, and act on a leader’s behalf for the 2026 Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115571119/en/ Scheduled for January 19–23 in Davos, Switzerland, th
Frasca to Supply Four New Flight Training Devices to Global Medical Response15.1.2026 16:05:00 CET | Press release
New Level 7 FTDs will support pilot training for emergency medical operations Frasca International, Inc., a FlightSafety International company, today announced it has signed a contract with Global Medical Response (GMR) to supply four new Level 7 Flight Training Devices (FTDs). The new devices include an Airbus EC135, a Pilatus PC-12, a Beechcraft C90, and a Beechcraft B200. Each FTD will feature Frasca's unique motion system to provide enhanced realism in training. The devices will be installed at GMR’s new training facility currently under construction in Denton, Texas. Frasca has supported GMR’s pilot training efforts for nearly two decades, beginning with the delivery of their first device in 2005 for Air Evac Lifeteam, a GMR company. Since then, Frasca simulators have played a central role in preparing GMR’s flight crews for the complex and high-stakes environments they encounter in emergency medical operations. With the delivery of these new devices, GMR will operate a total of 1
illumynt Reports 60% Revenue Growth and Launches Global Innovation Center to Meet Rising Enterprise Security and Sustainability Demands15.1.2026 15:11:00 CET | Press release
illumynt an intelligent, security-first technology lifecycle partner, today announced significant growth and innovation milestones that position the company as a leader in the next evolution of the IT Asset Disposition (ITAD) industry—an industry increasingly shaped by artificial intelligence, accelerated hardware refresh cycles, and heightened regulatory scrutiny. Under the leadership of CEO Joerg Herbarth, illumynt continues to execute its mission to deliver intelligent, technology-driven lifecycle solutions that maximize sustainability, security, and recovery value for the world’s most compute-intensive organizations. In 2025, ITAD became a strategic imperative. AI-driven workloads have dramatically compressed infrastructure lifecycles, while updates to NIST SP 800-88 Rev. 2, adoption of R2v3, and the expansion of global privacy frameworks have raised expectations for auditability, transparency, and verified data security. As a result, ITAD has evolved from a back-end operational fu
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