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

A Race Is Never Won Alone: With La Tavolata, Barilla Brings the Paddock Family Together on the Monza Grid4.9.2026 12:18:00 CEST | Press release

A nearly 100-meter-long dinner table hosted more than 200 guests for an evening celebrating collaboration, trust and the bonds built beyond competition. On Thursday evening ahead of the Formula 1® Italian Grand Prix, Barilla transformed one of the sport’s fastest and most competitive environments into a place where the Paddock Family took center stage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902463001/en/ La Tavolata by Barilla on the starting grid of the Monza circuit. More than two hundred people gathered around a single table: drivers, Team Principals, mechanics, engineers, strategists, safety and medical car drivers, personal trainers, tire technicians. The individuals whose collaboration, precision and trust shape every race, every decision and every performance. A nearly 100-meter table set with plates and pasta. With the first-ever Tavolata organized by Barilla and F1, people from across the Formula 1® ecosy

Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 20264.9.2026 11:30:00 CEST | Press release

Aqara, a global leader in IoT, today announced a new lineup of smart lighting products and a global community platform for smart space creators, at IFA 2026 in Berlin. The announcements reflect Aqara's ongoing vision for AI-driven spatial intelligence — spaces that understand their users and adapt to how people actually live in them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904365343/en/ Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 2026 The new lighting series — spanning indoor and outdoor use — integrates seamlessly with Aqara's existing ecosystem of sensors, switches, and hubs, bringing complete whole-space lighting scenarios and automated controls to life. The new Aqara products showcased include the Floor Lamp T1, LED Downlight T2, LED Strip T2, Outdoor String Lights H1, and Permanent Outdoor Lights H1. In addition, the company will present Aqara Builder, a platform fo

Hyper Brings its Latest Range of Power, Connectivity and MacBook Accessories to IFA 20264.9.2026 07:00:00 CEST | Press release

The latest additions to Hyper's portfolio make everyday mobile setups more personal, portable and productive across work, creating and travel Messe Berlin – IFA 2026 (Hall 5.2, Stand 179) – Hyper®, an innovator of mobile accessories for Apple users, creators and mobile professionals, will showcase its latest lineup at IFA 2026, designed to make everyday mobile setups more personal, portable and productive across work, creating and travel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903870923/en/ Discover Hyper's latest MacBook accessories, power and connectivity solutions debuting at IFA 2026 Building on essential MacBook Neo accessories, the range expands across portable charging, privacy, workspace connectivity and carry solutions, led by HyperJuice Flex, Hyper’s colourful and accessible collection designed to make everyday power more portable and personal. “At IFA, we’re introducing an everyday ecosystem built aroun

Mainstay Medical Announces Two-Year Outcomes from RESTORE Clinical Trial of ReActiv8®3.9.2026 22:30:00 CEST | Press release

ReActiv8® Restorative Neurostimulation™ treatment group showed sustained improvements in measures of disability, pain and quality of life from the one-year to the two-year timepoints.83% of control group patients elected to cross over and receive ReActiv8 therapy after the one-year assessment.After one year of ReActiv8 therapy, the outcomes in the crossover group were indistinguishable from the treatment group at the same time point, confirming the effect is reproducible, robust, and not cohort specific. Mainstay Medical Holdings plc today announced the publication of the two-year assessment results from the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show continued improvements in back pain-related disability, pain and quality of life in the ReActiv8 treatment group, and improvements after one year of ReActiv8 therapy in the crossover group that were indistinguishable from the improvements shown by the treatment group

Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)3.9.2026 22:30:00 CEST | Press release

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to thirty-one newly hired non-executive employees. The equity awards were granted on September 1, 2026 and consisted of options to purchase an aggregate of 280,600 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 133,500 shares. The options have an exercise price per share equal to $13.24, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restr

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