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

2PointZero Group Signals Global Scale With Revenue Surge to AED 21.9 Billion and Net Profit of AED 7.7 Billion in H1 202631.7.2026 13:42:00 CEST | Press release

Group revenue growth supported by stable gross profit margin of 29%, and adjusted EBITDA of AED 5.0 billionGlobal expansion milestones include the completed sale of TAQA stake, and the acquisition of Traverse Midstream Partners in North America, Baobab Group in Africa, and 60.8% of ISEM in ItalyTIME ranks the Group 36th on the World’s Growth Leaders list for 2026, highlighting market stability, operational scale and disciplined approach to capital 2PointZero Group (ADX: 2POINTZERO), a leading Abu Dhabi-based investment holding firm, announced its financial results for the first half of 2026, reporting revenue of AED 21.9 billion and delivering a Group Net Profit of AED 7.7 billion. This robust performance is reflected in the Group’s adjusted EBITDA, which reached AED 5.0 billion after excluding fair value changes and one-offs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260731538982/en/ Samia Bouazza, CEO of 2PointZero (P

Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy31.7.2026 08:30:00 CEST | Press release

Approval based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival Datroway now approved for two breast cancer indications in the EU Datroway® (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinionof the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on result

Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate31.7.2026 08:30:00 CEST | Press release

Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. "FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing," said

SES: Disclosure of Share Buyback Transactions31.7.2026 07:30:00 CEST | Press release

In the time period from June 2, 2026 until and including June 23, 2026, a number of 213,167 shares were bought back within the framework of the share buyback of SES to meet obligations under SES’s Equity Based Compensation Plan (EBCP). Shares were bought back as follows: Day of purchase Aggregated volume in shares Daily weighted average acquisition price of shares (EUR) Market June 2, 2026 27,097 8.8727 DXE June 2, 2026 72,903 8.8556 ENX June 5, 2026 16,624 8.3723 DXE June 5, 2026 31,510 8.4266 ENX June 15, 2026 26,451 7.8423 XPAR June 17, 2026 26,812 7.3910 XPAR June 23, 2026 11,770 7.2200 XPAR The transactions in a detailed form are published on SES’s website: https://www.ses.com/investors/shareholder-information/share-buy-backs. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, busin

Half-Year Report on SES’s Liquidity Contract31.7.2026 07:30:00 CEST | Press release

Pursuant to the liquidity contract entered into by SES with BNP Paribas as of 7 April 2026, please see the below update on the progress of the liquidity services. When the liquidity services were implemented as of 7 April 2026, the following assets were in the liquidity account: € 2,500,000 As of 30 June 2026, the following assets appeared on the liquidity account: 228,186 shares; € 816,880. Over the period from 7 April 2026 to 30 June 2026, the following transactions were executed: 1,082 buy transactions; 1,308 sales transactions. Over this same period, the volumes traded represented: 1,093,335 shares and € 8,485,986 on the buy side; 873,399 shares and € 6,860,843 on the sell side. Follow us on: LinkedIn | Facebook | YouTube | X | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, businesses grow, and people stay connected—no matter where th

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