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
INNIO Group Announces Filing of Registration Statement for Proposed Initial Public Offering11.5.2026 21:49:00 CEST | Press release
INNIO Group ("INNIO"), a leading global distributed energy solutions provider, today announces that it has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of its common shares. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511389675/en/ INNIO Group Announces Filing of Registration Statement for Proposed Initial Public Offering The timing of the offering, number of shares to be offered and the price range for the proposed offering have not yet been determined. INNIO has applied to list its common shares on the Nasdaq Global Select Market under the ticker symbol "INIO." Goldman Sachs & Co. LLC, J.P. Morgan and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. BofA Securities, Barclays and Citigroup are acting as book-running managers for the proposed offering. Baird, BNP Paribas
Only 7% of Companies Achieve Full Compliance as Global Expansion Increases Legal Complexity11.5.2026 15:00:00 CEST | Press release
47% of general counsels say beneficial ownership rules pose the biggest risks to legal operations44% lack confidence in meeting cross-border data security requirements As businesses accelerate their global expansion in 2026, compliance fails to keep pace. In fact, only 7% of organizations report full compliance across their global entities, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC surveyed 350 general counsel (GCs) and senior legal professionals across Europe, North America, and Asia Pacific to examine how their teams navigate international expansion, regulatory pressure, and the increasing adoption of artificial intelligence (AI).¹ The findings appear in CSC’s latest report, General Counsel Barometer 2026: From Complexity to Control. Most organizations report partial compliance, with over half (53%) estimating they are 50–75% compliant, and a further 35% placing themselves between 76%–99%. This leaves just 7%
IFF Opens Vanilla Innovation Center in Madagascar11.5.2026 14:15:00 CEST | Press release
Advancing science‑led flavor innovation where vanilla is grown IFF (NYSE: IFF)—a global leader in flavors, fragrances, food ingredients, health & bioscience—today announced the opening of its Vanilla Innovation Center in Madagascar, reinforcing vanilla as a strategic and priority tonality for IFF and strengthening its ability to innovate at origin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508110162/en/ IFF's Vanilla Innovation Center in Madagascar “The opening of the center marks an important step in how we approach vanilla innovation,” said Adam Jańczuk, Ph.D., senior vice president, research, creation and design, Taste, IFF. “By strengthening our presence at origin, we connect science, creativity and sustainability more closely, responding to climate changes, safeguarding quality and creating value across the supply chain.” Located in Toamasina, Madagascar’s principal seaport, near vanilla growing areas and post‑h
ARIS Recognised as a Leader in Gartner® Magic Quadrant™ for Process Intelligence Platforms, Believes This Reinforces Its Role in Enabling Enterprise AI at Scale11.5.2026 14:00:00 CEST | Press release
ARIS, the process context foundation platform for enterprise AI deployment, today announced its recognition as a Leader in the Gartner® Magic Quadrant™ for Process Intelligence Platforms. This is the fourth consecutive year that ARIS has been recognized as a Leader in the report and the company believes it underscores a continued commitment to innovation and growth as enterprises focus on turning AI ambition into measurable business outcomes. While technology has advanced rapidly, companies are struggling to operationalise AI across complex operating models. ARIS sees this recognition by Gartner as a reflection of its strength in delivering a single unified platform for process intelligence, providing the context layer on which G2000 organisations can successfully deploy and scale agentic AI. “AI is moving from experimentation to execution – but many enterprises are finding it difficult to scale,” said Guillaume Bacuvier, CEO of ARIS. “The reason is simple: AI lacks the context it need
HistoSonics Moves to Advance Additional Histotripsy Applications Announcing FDA Submission for Kidney Tumors11.5.2026 14:00:00 CEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced it has submitted a De Novo request to the U.S. Food and Drug Administration seeking authorization to expand the use of its Edison® Histotripsy System to include the destruction of kidney (renal) tumors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511268688/en/ HistoSonics Edison® Histotripsy System This milestone marks a significant step forward in the company’s mission to transform the treatment of solid tumors with a completely non-invasive technology that harnesses focused ultrasound to mechanically liquefy and destroy targeted tissue, reducing the risk of many complications and side effects associated with surgery, radiation, and other common therapies. “This submission is an important milestone in expanding histotripsy beyond the liver and into the kidney, an area where patients and physicians are s
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