MOBIDIAG
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
Original “Titanic Cherub” From James Cameron’s Epic Film Heads to Auction December 9 & 1024.11.2025 21:48:00 CET | Press release
Iconic Hollywood Artifact Indelibly Linked with “Jack & Rose” Portrayed by Kate Winslet and Leonardo DiCaprio One of the most recognizable and beloved set pieces from James Cameron’s Titanic heads to auction on December 9 &10 —the original Grand Staircase Cherub, seen in multiple scenes of the 1997 blockbuster, including the pivotal moment when Jack and Rose meet in front of the First Class Dining Room and the climactic moment when the Atlantic Ocean bursts through the skylight and floods the staircase, and cherub. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124056883/en/ The iconic “cherub” with Leonardo DiCaprio & Kate Winslet in James Cameron’s “TITANIC”. The ornate fixture—crafted for the full-scale recreation of Titanic’s Grand Staircase—was gifted by the production to Martin Biallas, CEO of SEE Global Entertainment, whose immersive exhibitions have brought the world’s most famous ship to millions of fans. It now
Access Advance Announces Major Growth in Its HEVC and VVC Patent Pools24.11.2025 16:10:00 CET | Press release
Access Advance LLC today announced significant expansions of both its HEVC Advance and VVC Advance Patent Pools during the second and third quarters of 2025, underscoring continued industry confidence in the company's balanced and transparent approach to video codec licensing. This growth follows the successful January 2025 launch of Access Advance's Video Distribution Patent ("VDP") Pool, demonstrating the company's expanding role in comprehensive video codec patent licensing solutions. Among the many highlights, Sharp Corporation joined the HEVC Advance Patent Pool as a Licensor, bringing valuable intellectual property assets to the pool's already extensive patent portfolio. Additionally, Huawei Technologies Co., Ltd., already an HEVC Advance Licensor and Licensee, expanded its collaboration with Access Advance by joining the VVC Advance Patent Pool as a Licensee. HP Inc. also expanded its license to include the VVC Advance Patent Pool after previously joining HEVC Advance in 2024, w
Microsize and Schedio Group to Acquire Lonza’s Micro-Macinazione Site in Switzerland24.11.2025 15:05:00 CET | Press release
Microsize, a leading CDMO specializing in particle size reduction and control technologies, today announced it has signed an agreement to acquire Micro-Macinazione (Mic Mac), a dedicated micronization facility in Monteggio, Switzerland, from Lonza. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124545344/en/ The agreement represents Microsize’s second acquisition from Lonza, following the successful 2022 divestment of its Quakertown, Pennsylvania site. In this transaction, Schedio Group – a Swiss-based provider of jet mills, isolators, spray dryers, and engineering services – is investing alongside Microsize to strengthen and localize its operational base in Europe, advancing a shared vision to lead the next generation of integrated particle engineering solutions. With more than 30 years of experience, Mic Mac has served the pharmaceutical industry with proven GMP-compliant jet milling and micronization capabilities for b
Hytera to Debut S1 E at PMRExpo 202524.11.2025 14:17:00 CET | Press release
Hytera, a leading global provider of critical communications technologies and solutions, today introduced the S1 E, a business-ready, palm-sized two-way radio designed specifically for the retail sector, expanding the portfolio of S Series and providing one more option for retail users to choose for their daily operations. The S1 E will make its debut at PMRExpo, the Europe's premier trade fair for secure, mission- and business-critical communication, taking place from November 25th to 27th, 2025, at Koelnmesse in Cologne, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124768341/en/ Hytera New Released Licence-free Analogue Business Radio S1 E Adhering to the S Series’ signature design language, the S1 E combines a stylish, modern, and minimalist aesthetic with practical functionality. Weighing under 85g, the S1 E provides all-day wearing comfort without tugging or weighing down uniforms. Key enhancements and sta
Merck Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis24.11.2025 14:00:00 CET | Press release
Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia GravisCladribine capsules has received Fast Track designation and Orphan Drug Designation by the US FDAMerck has established an MG patient council to provide insights on how to best meet the needs of patients in the gMG rare disease community Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for cladribine capsules for the treatment of the rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia Gravis (gMG). In June 2023, the FDA granted Orphan Drug Designation for cladribine capsules for the treatment of gMG. In addition, the Company is actively collaborating with patient organizations and Ad Scientiam, a medical technology company, to support a patient-directed approach to the future management of gMG. If approved
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