Business Wire

MOBIDIAG

Share
Mobidiag Receives CE-IVD Marking for Amplidiag® RESP-4 for Simultaneous Detection of COVID-19, Flu A, Flu B and RSV

Mobidiag Ltd. today announces that it has received CE-IVD marking for its Amplidiag® RESP-4 molecular diagnostic test for the rapid and simultaneous detection of some of the most prevalent respiratory viruses: SARS-CoV-2 (responsible for COVID-19 infection), Influenza A, Influenza B and RSV.

These viruses present similar symptoms, making it difficult for physicians to determine accurately which virus a patient has. The Amplidiag® RESP-4 assay can rapidly and simultaneously determine an accurate diagnosis from one patient sample using nasopharyngeal swabs, helping to guide clinicians to the relevant treatment decision for each patient. The test runs on the Mobidiag Amplidiag® Easy platform , which provides clinicians with an optimized sample screening process, with automated DNA/RNA extraction and PCR plate setup. Based on well-established high-throughput PCR technology, the platform can process 46 samples in approximately three hours.

This new test further broadens Mobidiag’s already available portfolio of diagnostics tests.

Tuomas Tenkanen, CEO of Mobidiag said, “We are very pleased to announce the CE-IVD marking for the Amplidiag® RESP-4 assay, which is highly relevant to both the traditional flu season and COVID-19. Symptoms caused by these viruses [SARS-CoV-2, Influenza A, Influenza B and RSV] can be very similar, and it is imperative that healthcare professionals are able to rapidly distinguish between them, in order to start the appropriate treatment for the benefit of patients.

In response to the growing need for fast and reliable diagnostics, at Mobidiag we are putting all our efforts into maintaining a high degree of autonomy in the production of our Amplidiag® tests by securing critical components to provide continuous support for our customers, as we all work together to control the spread of COVID-19.”

Mobidiag is currently developing Novodiag® RESP-4, a molecular diagnostic test using its Novodiag® platform for the rapid and on-demand detection of SARS-CoV-2, Influenza A, Influenza B and RSV. This test will complement Amplidiag® RESP-4 and enable clinicians to detect respiratory viruses to support early decisions in managing efficiently epidemiological and infection control measures, isolate patients in a timely manner, and ultimately improve patient care and outcomes.

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 have any symptoms of respiratory infections.

Notes to editors

About Mobidiag Ltd

Mobidiag is a fast-growing molecular diagnostics company whose rapid, 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

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

Notice Concerning Change of Representative Executive Officer14.1.2026 08:14:00 CET | Press release

H.U. Group Holdings, Inc. (the Company) today announced that it has resolved, at a meeting of the Board of Directors held on January 14, 2026, to change the Company’s Representative Executive Officer as described below. 1. Name and job titles of newly appointed Representative Executive Officer Name New title Current title Goki Ishikawa Representative Executive Officer, President and Group CEO Managing Executive Officer 2. Name and job titles of retiring Representative Executive Officer Name New title Current title Shigekazu Takeuchi Director and Executive Officer Director, Representative Executive Officer, Chairman, President and Group CEO 3. Reason for change In May 2025, toward realizing its Vision for 2035, the Company announced its Medium-Term Management Plan “H.U. 2030” (MMP) as well as its CEO succession plan including the timing for the selection of the next CEO. As the succession plan progressed, the Company has recognized that Mr. Goki Ishikawa is the best to lead the executio

TOXINS 2026: Clinical Updates on Galderma’s Leading Neuromodulator Portfolio Further Reinforce Its Leadership in Injectable Aesthetics14.1.2026 07:00:00 CET | Press release

Galderma will present data on Relfydess® (RelabotulinumtoxinA) – the first and only ready-to-use liquid neuromodulator designed with PEARL™ Technology – which further demonstrate its rapid onset and efficacy through 6 months in both moderate-to-severe frown lines (glabellar lines) and crow’s feet (lateral canthal lines)1-3 Dysport® (AbobotulinumtoxinA) data demonstrating high levels of patient and practitioner satisfaction after treatment of frown lines will also be presented4,5 Galderma will also present a Masterclass on the science behind Relfydess, demonstrating how the company is shaping the future of neuromodulation Galderma (SIX: GALD) will present data on its innovative and industry-leading neuromodulator portfolio at the TOXINS 2026 International Conference in Madrid, Spain from January 14-17, 2026. The company will share data from five abstracts on two neuromodulators from its portfolio, Relfydess – the first and only ready-to-use liquid neuromodulator designed with PEARL Tech

Zayed Sustainability Prize Honours Global Pioneers Advancing Progress14.1.2026 02:35:00 CET | Press release

US$5.9M awarded to 11 organisations and high schools from the UAE, Brazil, Canada, Nepal, Switzerland, Uganda and across six sustainability categories From AI-enabled diagnostics to Cooling-as-a-Service, this year’s winners deliver locally adapted innovations that empower millions In 18 years, the Prize has scaled solutions reaching more than 411 million people globally The Zayed Sustainability Prize, the UAE’s pioneering award for innovative solutions to global challenges, today announced the cohort of 2026 winners, celebrating 18 years of empowering communities and driving inclusive, sustainable progress around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113958706/en/ The 2026 winners of the Zayed Sustainability Prize were recognised by the President of the UAE in Abu Dhabi on 13 January 2026 (Photo: AETOSWire) In a ceremony held during Abu Dhabi Sustainability Week (ADSW) and attended by Heads of State, M

Alta Semper Secures USD 57.5 Million from EIB Group and IFC for Growth Fund II to Expand Healthcare Access Across Africa13.1.2026 19:30:00 CET | Press release

Alta Semper Capital LLP (“Alta Semper”), a London-based private equity firm focused on healthcare and consumer investments in high-growth markets, today announced that it has secured USD 57.5 million in commitments to Alta Semper Growth Fund II. These commitments come from a consortium of investors including the European Investment Bank (EIB) Group and the International Finance Corporation (IFC). This landmark partnership was signified earlier today with a momentous signing ceremony held at a Government Ministry in Cairo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113837616/en/ Andrew McDowell (EIB), Cheick Oumar Sylla (IFC), Gelsomina Vigliotti (EIB), Rania Al-Mashat (Minister of Planning, Economic Development and International Cooperation of Egypt), Bassel Rahmy (MSMEDA), Afsane Jetha (CEO, Alta Semper) and Mark Bryson-Richardson MBE (British Ambassador to Egypt) at the signing ceremony in Cairo. (Photo: AETOSWire)

500 Global and Creators HQ Support Creators and Founders Building Startups Collectively Valued at US$130M+13.1.2026 17:00:00 CET | Press release

500 Global, one of the world’s most active Silicon Valley-based venture capital firms1, and Creators HQ, the first content creator hub in the UAE and the Middle East enabling the creator ecosystem globally, announced the Creators Ventures Accelerator program is building and supporting creator-led startups collectively valued at over US$130 million.2 The Creators Ventures Accelerator received over 1,100 applications from content creators and technology startup founders across more than 70 countries. Following a competitive selection process, 21 creators and founders were chosen for the program. This cohort serves a community of 20M+ followers, subscribers, and users across platforms. “Creators represent a growing class of bona fide entrepreneurs, with 50 million creators globally, projected to grow at 10-20% annually over the next 5 years. The first iteration of this industry was built on visibility and virality to monetize. With consumers getting savvier and more discerning, we believe

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