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
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease1.5.2026 23:28:00 CEST | Press release
Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib)Once-daily Jakafi XR was shown to provide consistent, day-long exposure comparable to twice-daily JakafiJakafi XR will be available for pharmacy orders by May 8 Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501334677/en/ “The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meetin
Barilla Hosts Surprise Formula 1® Family Reunion Dinner During Miami Race Weekend1.5.2026 18:08:00 CEST | Press release
Drivers and team members of Formula 1® were reunited with their loved ones during a night that also celebrated the new partnership between Barilla and the Visa Cash App Racing Bulls Formula 1® Team. A special invitation, a table, and a plate of pasta shared by people who are often apart. That’s all it took for Barilla to bring the spirit of togetherness to Miami during the opening day of the FORMULA 1® CRYPTO.COM MIAMI GRAND PRIX 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430832316/en/ Barilla hosts Arvid Lindblad, Mikaela Shiffrin, and Nico Rosberg with Chef Massimo Bottura at Torno Subito, where the Formula 1® community came together for a surprise dinner. Barilla, the Official Pasta Partner of Formula 1®, welcomed team members and their families to Torno Subito Miami, the restaurant by three-Michelin-starred Chef Massimo Bottura, with the kitchen led by Chef Bernardo Paladini, for an evening where engines wer
TIME Names Xenco Medical one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health1.5.2026 12:07:00 CEST | Press release
Time Magazine has named pioneering medical technology company Xenco Medical as one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health. Widely regarded as the most prestigious recognition in business and technology, being selected to the TIME100 List remains the most coveted accolade that a company can achieve globally. The TIME100 Impact Awards are given to only 5 recipients each year, making it the rarest of honors that a company can receive and a profound recognition of transformative, global impact. Xenco Medical was honored by Time as the sole recipient of the TIME100 Impact Award in Health in 2026, signifying its leading, global distinction in impact on healthcare. According to Time Magazine, the TIME100 Most Influential Companies list highlights “companies making an extraordinary impact around the world.” The honor bestowed by Time comes after Xenco Medical was named the 2025 Medical Device/ Diagnostics Company of the
Andersen Consulting styrker sine kompetencer inden for digital transformation med Weexa1.5.2026 10:07:00 CEST | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Weexa, en global leverandør af løsninger inden for digital transformation, B2B-integration og digitalisering af forsyningskæden. Med hovedsæde i Frankrig leverer Weexa end-to-end-tjenester, der hjælper organisationer med at optimere, sikre og skalere deres digitale økosystemer. Virksomheden specialiserer sig i styring af B2B-datastrømme og digitalisering, hvilket muliggør problemfri kommunikation mellem applikationer både internt og på tværs af organisationer gennem teknologier som EDI, API'er og e-fakturering. Weexa tilbyder også SAP-integration og supply chain-løsninger til styring af lager og transport, sideløbende med strategisk rådgivning, projektlevering og vedligeholdelse af tredjepartsapplikationer. Weexa betjener organisationer inden for fødevaresektoren, detailhandel, engros, logistik, transport, bilindustrien, sundheds- og mediesektoren og hjælper globale virksomheder med at optimere deres ydeevne samt at overholde de nyeste
Inspirit Capital Completes Acquisition of Kaplan Languages Group1.5.2026 01:17:00 CEST | Press release
Inspirit Capital, a specialist investor in corporate carve-outs, and Kaplan, the global education company, have announced the completion of Inspirit’s acquisition of Kaplan Languages Group (KLG) from Kaplan. Financial terms are not being disclosed. KLG, a leading global language education platform, comprises Kaplan International Languages, Alpadia Language Schools, Azurlingua, and ESL Education. Inspirit Capital will support KLG in delivering on its ambitious growth plans, whilst continuing its fundamental mission to transform lives through language education. The next phase of ownership will see the development and launch of a refreshed standalone brand identity for KLG, with further announcements to follow on this in due course. KLG will continue to use the Kaplan name under a transitional license from Kaplan, Inc. until a new brand is announced. About Kaplan Languages Group Since 2006, KLG has provided the highest quality language education and cultural immersion experiences. Kaplan
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