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
HM King Mohammed VI Presides Over the Launch Ceremony of the Aircraft Landing Gear Production Plant Project, Representing an Investment of €280 million by the Safran Group in Morocco13.2.2026 21:10:00 CET | Press release
His Majesty King Mohammed VI, may God assist Him, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur, a project that reinforces Morocco as a destination of choice and a true integrated industrial actor at the heart of the global economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213269786/en/ His Majesty King Mohammed VI, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur Considered one of the largest manufacturing centres in the world for Safran Landing Systems, the plant will represent an investment of more than EUR 280 million, create 500 jobs, and operate on 100% decarbonised energ
Sultan bin Ahmed visits Huawei R&D Centre and SMG in China13.2.2026 18:52:00 CET | Press release
His Highness Sheikh Sultan bin Ahmed bin Sultan Al Qasimi, Deputy Ruler of Sharjah and Chairman of the Sharjah Media Council, visited the Huawei Research and Development Centre and Shanghai Media Group (SMG) in Shanghai, People’s Republic of China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213682693/en/ Sultan bin Ahmed visits Huawei R&D Centre and SMG in China (Photo: AETOSWire) His Highness toured Huawei Village, which spans 2.2 million square metres and comprises over 100 buildings and laboratories, employing more than 30,000 staff. He observed the master plan of the village and its key facilities that support the company’s business strategy and product development. He also reviewed the specifications of the buildings, constructed to the highest standards, and the diverse services provided to employees, including restaurants, cafes, entertainment venues, and rest areas. The center also offers easy access via train
Andersen Global tilføjer samarbejdsfirmaet Pi Advisory13.2.2026 17:23:00 CET | Pressemeddelelse
Andersen Global styrker sine kompetencer i Afrika gennem en samarbejdsaftale med Pi Advisory, et finansielt rådgivningsfirma baseret i Angola og med afdelinger i Mozambique og Portugal. Pi Advisory tilbyder en bred række af ydelser, herunder fuld skatteservice, forretningssupport og outsourcing, finansiel rådgivning samt en bred vifte af selskabsrelaterede ydelser, der hjælper kunder med alt fra etablering af nye virksomhedsenheder til at navigere i lokale skatteregler. Firmaet integrerer principper for miljø-, samfunds- og ledelsesmæssige forhold (ESG) i sin drift, hvilket afspejler dets engagement i en bæredygtig forretningspraksis. "Dette samarbejde styrker vores evne til at støtte kunder med komplekse behov på tværs af jurisdiktioner," udtalte António Amaral Correia, partner hos Pi Advisory. "Gennem vores samarbejde med Andersen Global kan vi levere løsninger, der imødekommer de skiftende krav fra kunder på de portugisisktalende markeder såvel som globalt." Mark L. Vorsatz, global
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 11:15:00 CET | Press release
Partnership Strengthens Volue’s Position as a European Leader in Electrification Technology Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 10:30:00 CET | Press release
Acquisition strengthens ABB’s ability to deliver system-level advisory support at scale to help critical industries manage increasingly complex electrical infrastructures and safeguard energy resilience Enhances ABB’s Electrification Service division offering in power system studies, grid modelling and electrical risk management for data centers, pharmaceuticals and other critical industries Solidifies ABB at the electrical system level, embedding trusted advisory expertise at the point where operational risks, resilience and performance are defined ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential.
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