– 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.

Novodiag^® assay rapidly detects coronavirus and influenzas;
provides safety for users with a closed system;
easy to use with no need for highly trained personnel in high risk and hard to reach areas

Mobidiag Ltd. today announces that it has initiated development of a Novodiag^® molecular diagnostic test for the rapid and simultaneous detection of the novel coronavirus (strain 2019-nCoV) and influenza viruses.

The assay is being developed in partnership with Autobio Diagnostics (Autobio), the market leading Chinese clinical diagnostics company, and Automobi Molecular Diagnostics (Automobi), the joint venture launched by Mobidiag and Autobio in May 2019.

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).

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

Mobidiag will hold a symposium on December 16th from 12h45 to 13h45, in spoken French. The symposium will showcase the Company’s automated molecular diagnostics solutions, Amplidiag® and Novodiag®, and their state-of-the-art capabilities in the rapid identification of infectious diseases and antimicrobial drug resistance. At the event, a number of leading clinicians will present data and share their experience of using Mobidiag’s solutions.

The presentations will feature customer experiences of the Amplidiag® Stool Parasites test, and also initial feedback of the recently launched Novodiag® Stool Parasites test. The Amplidiag® H. pylori+ClariR and Novodiag® Bacterial GE tests, both currently in routine use in healthcare settings, will also be discussed at the symposium.

Confirmed speakers at the Mobidiag symposium include:
• Pamela Chauvin, Biologist, CHU Toulouse
• Frédéric Heluwaert, Doctor, Hepatic-Gastroenterology and Digestive Endoscopy department, CH Annecy
• Philippe Lehours, University Professor and Pharmacist, Director of the National Reference Center for Campylobacters and Helicobacters, CNR Bordeaux

Following the presentations, a demonstration of both Amplidiag® and Novodiag® solutions will be made at booth No.13, showcasing how Mobidiag can support the everyday work of healthcare practitioners.

Yann Marcy, President at Mobidiag France, commented: