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
ClickHouse Raises $400M Series D Led by Dragoneer to Accelerate Expansion Across Analytics and AI Infrastructure16.1.2026 15:30:00 CET | Press release
Company acquires Langfuse to enter LLM observability and introduces a native Postgres service to unify transactional and analytical workloads ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, announced today the close of its Series D financing, raising $400 million. The round was led by Dragoneer Investment Group, with participation from Bessemer Venture Partners, GIC, Index Ventures, Khosla Ventures, Lightspeed Venture Partners, accounts advised by T. Rowe Price Associates, Inc., and WCM Investment Management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260116008883/en/ ClickHouse Co-Founders (left to right): Yury Izrailevsky, Aaron Katz, Alexey Milovidov The financing follows a period of sustained, accelerating growth for ClickHouse. The company now serves more than 3,000 customers on its fully managed service, ClickHouse Cloud, with ARR growing more than 250 percent year over year
Qualcomm Announces Quarterly Cash Dividend16.1.2026 15:00:00 CET | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on March 26, 2026, to stockholders of record at the close of business on March 5, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing busine
Nominations open for The MIDORI Prize for Biodiversity 2026 by AEON Environmental Foundation and the Secretariat of the Convention on Biological Diversity16.1.2026 09:00:00 CET | Press release
The MIDORI Prize recognizes outstanding individual contributions to the conservation and sustainable use of biodiversityThe unique prize contributes to raising public awareness of the essential role biodiversity plays for human well-being and in addressing global challenges such as climate changeThe Award Ceremony and Award Winners Forum will be held on 27 August 2026 in Tokyo, Japan The call for nominations for The MIDORI Prize for Biodiversity 2026 is open from 2 February to 31 March 2026. Nominations are invited from members of the public through the AEON Environmental Foundation website at https://www.aeonkankyozaidan.or.jp/en/prize/. The Award Ceremony and Award Winners Forum of the 2026 edition of the Prize will be held on 27 August in Tokyo, Japan. These events will contribute to the global mobilization around COP 17 of the Convention on Biological Diversity (CBD), which will take place in Yerevan (Armenia) under the theme of “Taking action for Nature”. Co-organized by the AEON
Tigo Energy and Weco Certify MLPE-Inverter Compatibility to Simplify PV System Design16.1.2026 06:00:00 CET | Press release
Tigo MLPE technology and hybrid inverters of Italian manufacturer Weco are now certified to work together to enhance design flexibility, system performance, and seamless integration. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the Company has signed a certificate of compatibility with Weco S.r.l., documenting the compatibility between Tigo Flex MLPE products and hybrid solar inverters from Weco. The certification covers certain single-phase and three-phase Weco products and members of the Tigo TS4-A and TS4-X product families, when properly designed and installed. Together, these products are designed to deliver high-quality, enhanced value through a system that generates and manages solar energy more efficiently and delivers the features residential energy customers demand. “The compatibility between our inverter solutions and Tigo optimizers represents a significant step forward for the
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
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