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
Peter Rauch Named President of Mountain Hardwear11.9.2026 01:00:00 CEST | Press release
Columbia Sportswear Company (Nasdaq: COLM), a leading innovator in active outdoor apparel, footwear, accessories and equipment, today announced that Peter Rauch will be the new President of the Mountain Hardwear brand. Mountain Hardwear's mission is to encourage and equip people to seek wilder paths. With over 30 years of wild wisdom, Mountain Hardwear continues to offer premium technical apparel, accessories and equipment products for climbers, mountaineers, skiers, snowboarders, and trail athletes. Troy Sicotte will transition to a new role as Global Vice President, Sales for Mountain Hardwear. Mr. Rauch transitions from his current role as General Manager of Columbia Brand North America and brings nearly 20 years of leadership experience across the Columbia family of brands, deep industry knowledge and a genuine passion for the outdoors. "Throughout his career, Peter has built strong cross-functional partnerships, developed high-performing teams, and delivered meaningful business re
The LYCRA Company Makes NSC Safety Congress & Expo Debut10.9.2026 19:45:00 CEST | Press release
Highlights Innovative Fibers That Enhance Worker Comfort, Performance, and Protection The LYCRA Company, a global leader in developing fiber and technology solutions for the apparel and personal care industries, today announced its inaugural exhibition at the NSC Safety Congress & Expo, being held September 14-16 in Indianapolis. The company also marks the North American debut of its “FIBERS THATWORK” portfolio of innovative solutions for workwear, uniforms, and protective apparel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910402207/en/ The LYCRA Company will debut its FIBERS THAT WORK portfolio at the NSC Safety Congress & Expo in Indianapolis, highlighting fiber technologies engineered to enhance comfort, durability, visibility, and protection in workwear and protective apparel. "Comfort is fundamental to workwear performance," said Tara Maurer-Mackay, product category director, branded specialty products at The LY
Turning Up the Heat: ProAmpac Helps Power Circle K’s Flamin’ Hot® Boneless Chicken Wings Launch10.9.2026 18:12:00 CEST | Press release
ProAmpac, a global leader in flexible packaging and material science, is proud to announce its role in supporting Circle K's launch of Flamin' Hot® Boneless Chicken Wings, created in partnership with PepsiCo/Frito-Lay. Designed to address key challenges in hot food packaging, ProAmpac's custom fiber-based tray helps maintain food quality, improve shelf appeal, and enhance the consumer experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910495607/en/ Flamin' Hot Chicken Bites Circle K sought a better way to merchandise its Flamin’ Hot® Boneless Chicken Wings while addressing several performance challenges, including heat retention, moisture loss, and grease resistance, while extending hot hold time. ProAmpac responded with a custom tray designed specifically for the recipe and portion size, demonstrating its flexibility in meeting unique customer design and performance requirements. Working from PepsiCo’s initial br
Record Currency Management wins new FX Alpha and Frontier Market mandates10.9.2026 17:30:00 CEST | Press release
Record Currency Management Ltd (RCM), a subsidiary of London-listed Record plc (Record Financial Group), is pleased to announce that it has been awarded two new mandates of strategic importance – an FX Alpha mandate and an FX Frontier mandate. RCM is the UK currency management arm of Record Financial Group, the London-listed specialist investment group managing over USD 122 billion of assets on behalf of institutional clients worldwide. Record’s client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. Headquartered in London, Record has offices in Hamburg, Zurich, Zug, New York, and Hong Kong. For institutional investors, currency can represent both a source of risk and a potential source of differentiated returns. Live since 2012, Record’s FX Alpha strategy aims to deliver attractive risk-adjusted returns without cap
Azizi Developments Introduces USD 8.1 Billion Master-Planned Community Azizi Florence in Sharjah10.9.2026 16:08:00 CEST | Press release
Azizi Developments, a leading private developer in the UAE, is unveiling Azizi Florence, a USD 8.1 billion master-planned community marking its first project in Sharjah. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910091949/en/ Azizi Florence (Photo: AETOSWire) The freehold development will feature 1,130 villas, more than 6,000 townhouses and 3,500 apartments, with three-bedroom townhouses starting from USD 515,000 at USD 231 per square foot of sellable area. Designed as an integrated destination, Azizi Florence will bring together residential, retail, hospitality, education, leisure and wellness offerings, centred around a 1.7-million-square-foot Central Park. Six residential clusters will each feature a park, clubhouse, community centre and landscaped gardens. Mr. Mirwais Azizi, Founder and Chairman of Azizi Group, said: “Returning to Sharjah after more than three decades is deeply meaningful to me, as this emirate w
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