Search Results for: novodiag

CE-IVD marking of Novodiag^® CarbaR+, the 3rd molecular test on the automated system Novodiag^®, for detection of the main Carbapenemase-Producing Enterobacteriaceae (CPE) and colistin resistance markers in one single test.

ESPOO, Finland, January 7^th, 2019 – Mobidiag Ltd. today announces the CE-IVD marking of Novodiag^® CarbaR+. Novodiag^® CarbaR+ is a single molecular test allowing fully automated detection of Carbapenemase-Producing Enterobacteriaceae (CPE), and associated resistance markers. CPE are bacteria that are resistant to carbapenem class of antibiotics. In addition, Novodiag^® CarbaR+ identifies a plasmid-mediated resistance to colistin. Colistin is considered the drug of last resort for many infections.

New molecular diagnostic test for the simultaneous detection of most common enteric pathogens directly from stool samples.
Espoo, Finland, April 17^th, 2018 – Mobidiag today announced the launch of Novodiag^® Bacterial GE+, a molecular diagnostic test for the simultaneous detection of most common enteric pathogens directly from stool samples. Compatible with the fully automated Novodiag^® system launched at the end of 2017, this new disposable cartridge allows direct analysis of a patient sample and delivers comprehensive results in about an hour, compared to days with currently used culture methods.

Through the implementation of cutting-edge production lines from Ginolis, Mobidiag will be able to answer growing needs in molecular diagnostics for routine use and anticipate the production of upcoming Novodiag^® test cartridges.
ESPOO, Finland, March 5, 2018 – Mobidiag Ltd, a Finnish molecular diagnostics for infectious diseases company, today announced it has signed an agreement with Ginolis, expert in assembly automation and high precision liquid handling solutions. Through the implementation of cutting-edge production lines from Ginolis, Mobidiag will be able to answer growing needs in molecular diagnostics for routine use and anticipate the production of upcoming Novodiag^® test cartridges.

The end of 2017 has been marked by a key event for Mobidiag, the launch of the Novodiag^® solution at the Finnish Embassy in Paris (France) with the support of M. Ambroise Fayolle, VP of the EIB (European Investment Bank) and Dr. Etienne Ruppé, MCU-PH/Associate Professor, bacteriology department at Bichat hospital (Paris, France).

The new Novodiag^® solution allows direct analysis of a patient sample placed in a disposable cartridge and delivers comprehensive results within a few hours. In a time where antibiotic resistance is a major threat for global health, the optimized process offered by Novodiag allows, among other things, to detect antibiotic resistance and limit the systematic use of antibiotics. This instrument allows detection of infectious diseases in a few hours and supports infection management accordingly.

PRESS RELEASE

Mobidiag Secures 15 Million Euros from EIB to Accelerate the Launch of its Novodiag^® Platform and Suite of In Vitro Diagnostic Tests

PORI, Finland, July 14th, 2016 – Mobidiag Oy, a Finnish molecular diagnostics company, today announced that it has signed a 15 million euro loan with the European Investment Bank Group. As part of the InnovFin initiative, the loan will allow Mobidiag to finalize and scale up Novodiag^®products manufacturing, assay validation and commercialization over the next 3 years. The operation is supported by ‘InnovFin – EU Finance for Innovators’, with the financial backing of the European Union under Horizon 2020 Financial Instruments.

Transaction Will Accelerate Global Growth of Mobidiag’s Differentiated Molecular Platform, which Offers Ease of Use, Multiplex Capability and Rapid Turnaround Time —

ESPOO, Finland, April 08, 2021 — Mobidiag Oy, a privately held, commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation, announced today that it has signed a definitive agreement to be acquired by Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, for an enterprise value of approximately €668 million ($795 million).  This includes a cash payment of approximately €600 million ($714 million) for Mobidiag’s equity, and net debt of approximately €68 million ($81 million).

• Real-time PCR-based test enables high-throughput reliable detection of most prevalent respiratory infections, including COVID-19
• One single test determines the virus responsible for patient symptoms, guiding treatment decisions and rapid isolation strategy if required

FINLAND, Espoo, March 1^st, 2021 – 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.

2020 was an unprecedented year as the world faced the unexpected and rapid spread of coronavirus. As the pandemic extends into 2021, we have been witnessing specific new variants spreading rapidly in the United Kingdom, South Africa and Brazil.

These new variants will however not impact the performance of our molecular assays Amplidiag COVID-19, nor Novodiag COVID-19, which utilise targets for N gene and Orf1ab. The new coronavirus variants potentially have an impact on assays using the S protein as a target, which is not the case for Mobidiag tests. At Mobidiag, it is part of our routine post-market surveillance to monitor for new coronavirus variants and developments to ensure that the performance of our assays is always suitable for the market.

• Second tranche of €10M from €25M growth capital loan signed with the European Investment Bank in May 2019
• New funds will be used to accelerate the development, manufacturing and commercialisation of in vitro diagnostics for infectious diseases

Mobidiag Ltd. today announces that it has received the second tranche of €10M from the €25M growth capital loan signed with the European Investment Bank Group (EIB) in May 2019. These new funds will be used to advance Mobidiag’s research and development and facilitate further validation and commercialisation of new molecular diagnostics tests using the Company’s Amplidiag^® and Novodiag^® platforms.

The loan is supported by the European Fund for Strategic Investments (EFSI), the main pillar of Investment Plan for Europe, through the European Growth Finance Facility (EGFF) initiative. This is the second operation between Mobidiag and EIB, following the first loan in 2016 for €15M.