Search Results for: novodiag

• CE-IVD marked molecular diagnostic tests on the Novodiag and Amplidiag platforms for rapid detection of COVID-19 infections to support decisions for efficient patient isolation, treatment and release
• Antibody test for detection of past COVID-19 infections
• Secure supply chain and in-house manufacturing capabilities to meet demand

Mobidiag Ltd. 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.

– Real-time PCR-based test enables high-throughput reliable detection of early COVID-19 infections for rapid isolation and treatment guidance

– Currently set up for routine use in main Finnish clinical labs with capacity to test up to 4,000 samples per day

Mobidiag Ltd. announces that it has received emergency use authorization in Finland for its Amplidiag^® COVID-19 molecular diagnostic test for the rapid detection of the SARS-CoV-2 virus, responsible for novel coronavirus infection (COVID-19). The Amplidiag^® COVID-19 is now available for use in Finland*. The test will be run for routine use at the main clinical laboratories in Finland (Helsinki University Hospital (Huslab), SYNLAB and Mehiläinen) doubling Finnish testing capacity and allowing testing coverage for most of the country. The process for obtaining emergency use authorization is now ongoing in Sweden, UK and France. Mobidiag will register this test for CE-IVD mark and it should be available for widespread use in Europe in the coming weeks through Mobidiag’s sales teams and local distributors.

ESPOO, Finland, January 07, 2020 – Mobidiag Ltd., a revenue generating, molecular diagnostics company with complementary platforms that address antimicrobial resistance and other areas of unmet diagnostic need, today announces that it has been granted EUR 1.5 million ($1.65 million) additional funding from Business Finland (formerly Tekes) for the continued development of a rapid diagnostic test for sepsis using Mobidiag’s Novodiag platform. This additional funding has been secured as a result of strong progress in the development of the assay and the completion of key milestones by Mobidiag since the award of the first grant in May 2018. The new funding brings the total loan to EUR 3 million ($3.3 million).

PARIS, France, December 11th, 2019 – Mobidiag Ltd., a molecular diagnostics company with complementary platforms that address antimicrobial resistance and other areas of unmet diagnostic need, will host a symposium at the 39th Interdisciplinary Meeting of Anti-Infectious Chemotherapy (RICAI) conference in Paris, from the 16th to 17th of December.

The RICAI conference is an annual meeting bringing together leading French clinicians and microbiologists (parasitologists, virologists, bacteriologists) and innovative commercial companies in diagnostics.

FINLAND Espoo/CHINA, Zhengzhou, June 3 2019 – Mobidiag Ltd., a commercial stage molecular diagnostics company addressing the spread of antimicrobial resistance, today announces the launch of Automobi Molecular Diagnostics Co., Ltd (‘Automobi’), the joint venture (‘JV’) between Mobidiag and Autobio Diagnostics (‘Autobio’), one of the leading clinical diagnostics companies in China. Automobi is responsible for commercialising the Novodiag^® platform and selected infectious disease assays in the Greater China territory.

EIB Vice-President Alexander Stubb and Tuomas Tenkanen, CEO of Mobidiag (source: EIB)

Investment Plan for Europe: Mobidiag secures EUR 25 million from EIB

• Funds will be used to accelerate the development and commercialisation of in vitro diagnostic solutions for infectious diseases.
• Second operation between the EIB and Mobidiag after first loan in 2016.

Mobidiag Ltd., a commercial stage molecular diagnostics company addressing the spread of infectious diseases and antimicrobial resistance, has signed a EUR 25 million growth capital loan with the European Investment Bank (EIB). The EIB loan will be supported by the European Fund for Strategic Investments (EFSI), the main pillar of the Investment Plan for Europe, through the European Growth Finance Facility (EGFF) initiative. This new four-year loan will allow Mobidiag to advance its research and development and facilitate further validation and commercialisation of molecular diagnostics tests on the Company’s Amplidiag^® and Novodiag^® platforms.