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
Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva26.9.2026 01:00:00 CEST | Press release
-Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP-Atebrioz expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per month-PROGRESS pediatric development program continues to evaluate zilurgisertib in children aged 2 to <12 years Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (HO) in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). The recommended dose of Atebrioz is 100 mg administered orally, once daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925436454/en/ “Today marks an important milestone for pe
Digital Reef Signs Offtake Agreement with Oreasoc Agriculture to Mitigate the Environmental Footprint of Data Centre Growth Through Rainforest Protection, Appointing Xange.com as Digital MRV Partner25.9.2026 21:19:00 CEST | Press release
The offtake agreement connects Digital Reef’s 3.3 GW data centre pipeline with environmental assets from more than 30 million hectares of Amazon rainforest across South America, where Oreasoc Agriculture works directly on the ground alongside local communities to develop sustainable economies and safeguard their territories. Xange.com’s digital MRV technology monitors both the data centres and the rainforest. At Climate Week NYC, Digital Reef and Oreasoc Agriculture Inc. sign an offtake agreement connecting Digital Reef’s 3.3 GW data centre pipeline with environmental assets exceeding 30 million hectares of South American Amazon rainforest, mitigating the environmental footprint of data centre growth through rainforest protection and restoration where Oreasoc works alongside local communities to protect biodiversity, develop sustainable economies and safeguard their territories. Xange.com are appointed as digital MRV technology partner to monitor the data centres and rainforest where D
NetApp Announces Intent to Acquire PEAK:AIO to Advance Scalable AI Infrastructure Architecture25.9.2026 15:00:00 CEST | Press release
Planned acquisition strengthens NetApp's position in the rapidly growing AI infrastructure market by bringing differentiated metadata innovation and parallel file architecture designed for AI NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced its intent to acquire PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. The planned acquisition is expected to accelerate NetApp's AI infrastructure roadmap by augmenting metadata services and parallel namespace innovation designed to help AI clouds scale shared storage alongside growing GPU clusters. As AI becomes embedded in every enterprise workload, organizations are confronting a new challenge: traditional storage architectures were not designed for the unprecedented scale, concurrency, and performance requirements of AI factories, AI clouds, and next-generation data-intensive applications. NetApp is building an architecture that disaggregates metadata fr
MultiBank Group Secures Two Awards at Forex Expo Dubai 202625.9.2026 14:57:00 CEST | Press release
The Group was recognised for the strength of its global institutional ecosystem and its contribution to financial markets innovation and community impact MultiBank Group, one of the world’s largest financial derivatives institutions, received two awards during its participation at Forex Expo Dubai 2026, held on 22 and 23 September at Dubai World Trade Centre. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925539591/en/ MultiBank Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The first award recognised the strength and breadth of MultiBank Group’s global institutional offering, which brings together trading, liquidity
Croma-Pharma Introduces saypha® volume prime Lidocaine25.9.2026 14:04:00 CEST | Press release
New cross-linked hyaluronic acid filler replaces saypha® volume Lidocaine, offering physicians a more versatile solution for both midface volumization and nasolabial folds Croma-Pharma introduces saypha® volume prime Lidocaine, a cross-linked hyaluronic acid dermal filler that replaces saypha® volume Lidocaine within the company's saypha® portfolio. The new product offers physicians a more versatile solution with expanded indications for both midface volumization and nasolabial folds, backed by strong clinical data. 1,2 saypha® volume prime Lidocaine demonstrated non-inferiority to comparatora in a randomized, subject- and evaluator-blinded, controlled, non-inferiority multicenter, parallel group comparison study with almost 500 patients.2 In the clinical evaluation, a high patient satisfaction highlights improved midface fullness, smoothness and contour, consistent with a rheologic profile designed to provide volumization in the mobile midface.b,2 With saypha® volume prime Lidocaine,
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