Business Wire

MOBIDIAG

22.4.2020 06:02:09 CEST | Business Wire | Press release

Share
Novodiag® COVID-19, a Fully Automated Molecular Diagnostic Test from Mobidiag, Granted Emergency Use Authorization in Finland for Novel Coronavirus

Mobidiag Ltd., a revenue generating, molecular diagnostics company with complementary platforms that address antimicrobial resistance and other areas of unmet diagnostic need, today announces that it has received emergency use authorization in Finland for its Novodiag® COVID-19 molecular diagnostic test for the rapid and fully automated detection of the SARS-CoV-2 virus, responsible for novel coronavirus infection (COVID-19). The Novodiag® COVID-19 is now available for use in Finland*. The process for obtaining emergency use authorization is now ongoing in Sweden, UK and France.

The Novodiag® COVID-19 assay allows qualitative determination of SARS-CoV-2 (orf1ab and N genes) directly from nasopharyngeal swabs. The test will operate using the Novodiag® rapid ‘sample-in, result-out’ system, allowing the fully automated detection of novel coronavirus in approximately 1 hour. In addition, Novodiag® has 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 without the need for highly trained personnel.

This new test complements the emergency use test, Amplidiag® COVID-19 *, which is suitable for high-throughput screening, launched on 14 April 2020 . This test is now available in Finland and routinely used in the main Finnish clinical laboratories as well as in France where it has been validated by the National Center of Reference – Institut Pasteur.

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, the development of our proprietary mNAT™ sample buffer and collection tubes).

Tuomas Tenkanen, CEO of Mobidiag, said, “The coronavirus pandemic is a global challenge that needs all parts of industry to respond with innovative solutions for multiple settings. Early detection of COVID-19 infections is critical in supporting clinical decisions to efficiently manage epidemiological and infection control measures to isolate patients in a timely manner and to globally improve patient care. At Mobidiag, we have harnessed our existing technologies and expertise, including supply chain management and manufacturing, to rapidly develop and supply two coronavirus diagnostics tests, providing clinicians solutions suited to their own laboratory capacities. We are pleased that from today we are able to offer Novodiag® COVID-19 which can be used in smaller units without the need for highly trained personnel and Amplidiag® COVID-19 which can be used in larger laboratories for high-throughput testing”.

* Amplidiag® COVID-19 is now available in Finland and France as an emergency use test. Novodiag® COVID-19 is available in Finland only at this time. Please note that Mobidiag 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

Link:

ClickThru

Social Media:

https://www.facebook.com/mobidiag

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

LTM Launches GCC Origin: A New Independently Operated Business Unit for Next-Generation Global Capability Centers28.10.2026 06:04:00 CET | Press release

LTM, the Business Creativity partner to the world’s largest enterprises, today announced the launch of GCC Origin, a dedicated business unit to help enterprises establish, operate, scale and transform Global Capability Centers in India. As GCC needs evolve in the AI era, enterprises are seeking greater scale, speed and integration. GCC Origin represents the evolution of LTM’s GCC strategy to meet these changing needs. Operating as a standalone business unit within LTM, GCC Origin will have dedicated leadership, sales and delivery teams, specialist expertise and significant investment. LTM has appointed Shailendra Singh to lead the business unit, reporting to Venu Lambu, Chief Executive Officer and Managing Director, LTM. GCC Origin brings together strategy, AI, technology, talent, infrastructure, operations and ecosystem partnerships under one integrated model. Spanning site selection, workplace and infrastructure, operational readiness and turnkey facilities across Tier 1 and Tier 2 c

Hitachi Unveils a New Global Digital Services Company Turning Cloud, Data and AI Into Measurable Business Outcomes: Hitachi Digital28.10.2026 01:00:00 CET | Press release

Uniting GlobalLogic and Hitachi Digital Services under a single global brand, Hitachi Digital will deliver end-to-end capabilities that help organizations in complex, mission-critical industries drive business transformation Hitachi, Ltd. (TSE:6501, “Hitachi”) today announced plans to launch Hitachi Digital Inc. (“Hitachi Digital”), a new global digital services company, on April 1, 2027, in accordance with the integration plan announced in January 20261. Hitachi Digital will unite Hitachi’s U.S. subsidiaries, GlobalLogic Inc. (“GlobalLogic”) and Hitachi Digital Services LLC (“Hitachi Digital Services”) under a single company using the Hitachi brand, with a brand campaign launching today. Hitachi Digital will steadily guide enterprise digital transformation at the convergence of cloud, data and AI toward concrete business results. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027531796/en/ Hitachi unveils a new global di

Logitech Announces Q2 Fiscal Year 2027 Results27.10.2026 21:05:00 CET | Press release

Second Quarter Marks Company’s Eleventh Consecutive Quarter of Growth SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the second quarter of Fiscal Year 2027. Sales were $1.22 billion, up 3 percent in US dollars and 2 percent in constant currency, compared to Q2 of the prior year. GAAP gross margin was 44.9 percent, up 150 basis points compared to Q2 of the prior year. Non-GAAP gross margin was 45.2 percent, up 140 basis points compared to Q2 of the prior year. GAAP operating income was $201 million, up 5 percent compared to Q2 of the prior year. Non-GAAP operating income was $231 million, up 0.4 percent compared to Q2 of the prior year. GAAP earnings per share (EPS) was $1.25, up 9 percent compared to Q2 of the prior year. Non-GAAP EPS was $1.51, up 4 percent compared to Q2 of the prior year. Cash flow from operations was $164 million. The quarter-ending cash balance was $1.51 billio

Grid Dynamics Launches Business Process Consulting Practice to Bridge the Gap Between AI Investment and Business Results27.10.2026 21:05:00 CET | Press release

Key Takeaways: Grid Dynamics expands its enterprise AI transformation capabilities with a new Business Process Consulting practice enabling end-to-end AI transformation for Fortune 1000 enterprises. Integrated with Grid Dynamics' established AI engineering expertise, the practice helps enterprises identify business opportunities, provides investment justification to technology implementation and measurable value realization by enterprise-wide change management. The practice combines Grid Dynamics' ARC (Assess, Reengineer, Capture) methodology with a technology-driven approach to consulting, incorporating advanced AI capabilities into business process optimization and personalized, AI-powered change management. Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced the launch of its Business Process Consulting practice, extending the company's AI transformation capabilities across the entire AI adoption li

Hightouch Partners with Independent Media to Activate Reader and Commercial Data27.10.2026 17:01:00 CET | Press release

The partnership will help Independent Media deliver more relevant reader engagement, build premium advertising audiences, and support affiliate and e-commerce growth. Hightouch, the leading agentic marketing platform, today announced a partnership with Independent Media, publisher of The Independent. Independent Media will use Hightouch to connect its customer data to marketing tools. With Hightouch, the company will send readers more relevant membership and subscription offers, build stronger audiences for its advertising partners, and grow its affiliate and e-commerce business. “Deepening customer relationships and delivering real value to our commercial partners requires moving seamlessly from insight to action,” said Krishan Gandhi, Director of Data Intelligence and Monetisation at Independent Media. “Partnering with Hightouch allows us to utilise our warehouse data directly into our engagement tools, powering real-time, omnichannel journey orchestration, while enabling us to build

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye