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
Masimo SET® Pulse Oximetry Performed Accurately on Hospitalized Newborns of All Skin Tones in Largest-Ever Prospective Real-World Study28.4.2026 14:00:00 CEST | Press release
NICU Study Adds to the Evidence Demonstrating SET®’s Accuracy in Challenging Real-World Settings, With No Clinically Significant Differences in Performance Across Skin Pigmentation Categories or Race and Zero Occult Hypoxemia in Black or Hispanic Newborns Masimo (NASDAQ: MASI) today announced the findings of a study evaluating the accuracy of Masimo SET® pulse oximetry among critically ill neonates and demonstrating less than 1% overall statistical bias. Importantly, there were no clinically meaningful skin pigmentation-related discrepancies and no occult hypoxemic events among Black or Hispanic patients, and in only one Caucasian patient overall. The Neonatal Pulse Oximetry Accuracy and Disparities by Skin Pigmentation (NeoPODS) study findings were presented from the podium at the Pediatric Academic Society in Boston, MA on Monday, April 27th at 10 am EST by lead author Dr. Heather Siefkes on behalf of colleagues at the University of California, Davis and the University of Mississippi
KAYTUS AI Compute Pod Wins 2026 iF Design Award and Red Dot Award, Setting a New Standard for AI Data Center28.4.2026 11:54:00 CEST | Press release
Delivering up to 130kW of liquid cooling per rack, the solution synchronizes cooling output with IT load in real time within seconds, to support high-density AI, large-scale computing, and HPC deployments, while reducing build time by 70% KAYTUS, a leading provider in AI infrastructure and liquid-cooling solutions, announced that its AI Compute Pod has received both the 2026 iF Design Award and Red Dot Award. This dual recognition not only stems from its outstanding performance in green, low-energy operation—achieving up to 130 kW cooling capacity per rack and a PUE as low as 1.1 through optimized thermal and power design—but also from its innovative approach to intelligent control and efficient O&M. The solution enables second-level synchronization between cooling and IT workloads, and leverages a dual-group control strategy to improve cooling energy efficiency by over 10%. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260
Braskem to Showcase Sustainable Packaging Solutions at interpack 202628.4.2026 10:00:00 CEST | Press release
Braskem delivers scalable circular solutions that strengthen the packaging value chain and advance a lower‑carbon future. Braskem (B3: BRKM3, BRKM5, and BRKM6, NYSE: BAK, LATIBEX: XBRK) the largest polyolefins producer in the Americas, as well as a global market leader and pioneer producer of biopolymers on an industrial scale, will be at interpack 2026 in hall 9, booth A32, presenting packaging solutions made from bio-based, recycled and traditional polyolefins, enabling circular plastics, end-to-end. At interpack, Braskem will highlight I’m green™ bio‑based polyethylene grades specifically engineered for food‑contact applications, as well as Medcol V7040, a new grade for Healthcare and Hygiene. These innovations mark the first time Braskem has offered sustainably sourced sugarcane‑derived plastics for these segments. In an environment where packaging decisions are increasingly evaluated on both sustainability ambitions and business impact, Braskem positions itself as a materials part
Albion and Tecnotree Partner to Deliver Next-Generation VAS Platform for TELUS in North America28.4.2026 09:00:00 CEST | Press release
Albion, a leading provider of telecom managed services and solutions, today announced that TELUS has selected Albion, in partnership with Tecnotree, to deliver a next-generation Value-Added Services (VAS) platform, with an initial deployment of a voicemail application. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428959214/en/ Albion and Tecnotree Partner to Deliver Next-Generation VAS Platform for TELUS in North America Under the engagement, Albion will deliver the solution leveraging Tecnotree’s proven VAS and digital services platform, supporting TELUS’ objectives to modernize service capabilities; enhance the customer experience; and ensure scalable, future-ready service delivery. As part of the deployment, Albion will provide end-to-end managed services, including platform operations, service assurance, and ongoing lifecycle management, ensuring high availability and performance for TELUS customers across North Ame
Budweiser Partners with Football Icons Erling Haaland and Jürgen Klopp to Unleash New “Let it Pour” Platform for FIFA World Cup 2026™28.4.2026 09:00:00 CEST | Press release
The platform extends across more than forty countries, bringing fans together with a new global film featuring Haaland and Klopp, limited edition apparel, and legendary fan experiences Today, Budweiser, the Official Beer Sponsor of the FIFA World Cup 2026™, unveiled its newest global football platform, “Let It Pour,” cracking open four years' worth of anticipation for the game’s biggest stage. Activating across more than forty countries, the global beer icon is supercharging celebrations with Bud FC fan events, The Bud Fan Store, and a new global film calling the world together to Let It Pour. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428722336/en/ Budweiser Partners with Football Icons Erling Haaland and Jürgen Klopp to Unleash New “Let it Pour” Platform for FIFA World Cup 2026™ “For over four decades, Budweiser has been part of the celebrations that define the FIFA World Cup™, be it on the pitch, in bars, or wherev
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