Automated COVID-19 test given authorisation in Finland

Molecular diagnostics company Mobidiag has received emergency use authorisation in Finland for Novodiag COVID-19 test for the rapid and automated detection of the SARS-CoV-2 virus.

The process for obtaining emergency use authorisation is now ongoing in Sweden, UK and France.

The Novodiag COVID-19 assay allows qualitative determination of SARS-CoV-2 (orf1ab and N genes) directly from nasopharyngeal swabs. The test will operate using the Novodiag rapid ‘sample-in, result-out’ system, allowing the automated detection of novel coronavirus in approximately one hour.

It has a closed system aimed to ensure the protection of laboratory staff and healthcare professionals from possible contamination. Aimed to be user-friendly, it’s hoped the Novodiag system can also be used in high risk and hard to reach areas without the need for highly trained personnel. 

This new test complements the emergency use test, Amplidiag COVID-19, which is suitable for high-throughput screening. This test is now available in Finland and routinely used in the main Finnish clinical laboratories as well as in France where it has been validated by the National Center of Reference – Institut Pasteur.

Tuomas Tenkanen, CEO of Mobidiag, said: “The Coronavirus pandemic is a global challenge that needs all parts of industry to respond with innovative solutions for multiple settings. Early detection of COVID-19 infections is critical in supporting clinical decisions to efficiently manage epidemiological and infection control measures to isolate patients in a timely manner and to globally improve patient care. At Mobidiag, we have harnessed our existing technologies and expertise, including supply chain management and manufacturing, to rapidly develop and supply two coronavirus diagnostics tests, providing clinicians solutions suited to their own laboratory capacities. We are pleased that from today we are able to offer Novodiag COVID-19 which can be used in smaller units without the need for highly trained personnel and Amplidiag COVID-19 which can be used in larger laboratories for high-throughput testing.”