MOBIDIAG
2.6.2020 06:02:06 CEST | Business Wire | Press release
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
70% of Enterprise AI is Uncontrolled, Driving Hidden Risk, Cost and Slower ROI27.4.2026 10:00:00 CEST | Press release
Lenovo research highlights a growing AI execution gap as organizations struggle to control and operate AI across their environments AI is already being used across your organization, whether it has been formally approved or not. Employees are using AI with or without IT involvement, fueling the rise of ‘shadow AI’ across the enterprise, creating gaps in governance and control. This is no longer just an IT challenge. For Chief Information Security Officers, this shift is expanding the attack surface across devices, endpoints, and data flows, introducing unmanaged risk and increasing the likelihood of sensitive company data being exposed or accessed without proper controls. What this reveals is a growing AI execution gap: usage is accelerating, but control is not keeping pace. Based on a survey of 6,000 employees worldwide, Lenovo’s latest Work Reborn Report, Leading Your Workforce to Triumph with AI, finds that more than 70% of employees are using AI weekly, with up to one third operati
First Enterprise Quantum Computer Purchase in Japan: IQM to Deploy System to TOYO Corporation27.4.2026 08:00:00 CEST | Press release
First enterprise quantum computer purchase in Japan cements IQM's position as the global leader in deployed quantum computers The Radiance 20-qubit system will enable TOYO to explore various industry use cases, while advancing a hybrid quantum-HPC infrastructure. This will be the third quantum computer to be deployed by IQM in the Asia-Pacific region. IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the purchase of its full-stack 20-qubit quantum computer by TOYO Corporation, marking the first enterprise quantum system deployment in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426053944/en/ (From Left): Toshiya Kohno, Representative Director, President and CEO of TOYO Corporation, and Jan Goetz, CEO & Co-founder of IQM Quantum Computers. The Radiance 20-qubit system will be made available in both on-premises and cloud environments and will be delivered by the end of 2
SAP and S3NS Accelerate Trusted Cloud Adoption in France With Thales as First Strategic Customer27.4.2026 08:00:00 CEST | Press release
Thales adopts SAP RISE private cloud edition on S3NS to transform its ERP (Enterprise Resource Planning) landscape and operationalize digital sovereignty at scale. By combining SAP’s enterprise applications and Business AI capabilities with S3NS’s trusted infrastructure, this partnership unlocks cloud adoption for highly regulated sectors, including public administration, aerospace and defense, and operators of vital and essential services. Thales (Euronext Paris: HO): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426644177/en/ Strategic partnership (c)S3NS A decisive step in scaling trusted cloud in Europe The strategic partnership between SAP and S3NS, the trusted cloud provider established by Thales and Google Cloud, will strengthen trusted cloud capabilities in France and support Europe’s growing demand for cloud business transformation. SAP RISE private cloud edition will be deployed by SAP Sovereign Cloud on S3NS’
Murata Launches Ultra-Low Power AMR Sensors to Boost Battery Life in Healthcare and Wearables Devices27.4.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has commenced mass production of its MRMS166R and MRMS168R anisotropic magnetoresistance (AMR) sensors for healthcare, wearable, and IoT devices. The MRMS166R is the first AMR sensor to combine an average current consumption of 20 nA with operation from a 1.2 V supply, enabling extended battery life in coin cell-powered systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260413296947/en/ [Murata Manufacturing Co., Ltd.] AMR sensor The devices are solid-state magnetic sensors used for switching applications. They detect the presence or absence of a magnetic field and generate an output signal that system logic uses to control functions such as transitions between active and sleep modes. This enables contactless switching without mechanical components, improving reliability, and supporting sealed, miniaturized designs. Automatic switching between active and
Sun Pharma signs Definitive Agreement to Acquire Organon27.4.2026 01:51:00 CEST | Press release
Organon stockholders to receive US$ 14.00 per share in cashThe deal values Organon at EV of US$ 11.75 billionCombined Business leverages complementary portfolios and global scale for sustained long‑term value creation Sun Pharmaceutical Industries Limited(Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associated companies, “Sun Pharma”) and Organon & Co. (NYSE: OGN) (“Organon”) today announced that they have entered into a definitive agreement under which Sun Pharma will acquire all outstanding shares of Organon for US$ 14.00 per share in an all‑cash transaction with an enterprise valuation of US$ 11.75 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426881370/en/ Organon is a global healthcare company formed through a spinoff from Merck, known as MSD outside of the United States and Canada, in 2021. Organon has a legacy of deep trust and strong brand equit
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