Finnish molecular diagnostics firm Mobidiag has received emergency use authorisation (EUA) for its Novodiag COVID-19 molecular diagnostic test in Finland.
The test has been designed to facilitate the rapid and fully automated detection of SARS-CoV-2 virus that causes the novel coronavirus infection (COVID-19).
It is a real-time RT-PCR-based molecular test that provides fast, on-demand detection of early COVID-19 infections for quick isolation and treatment guidance.
The assay enables a qualitative determination of SARS-CoV-2 directly from nasopharyngeal swabs. It uses Novodiag rapid ‘sample-in, result-out’ system that supports fully automated detection of COVID-19 in one hour.
Additionally, the Novodiag closed system ensures the protection of laboratory staff and healthcare professionals from potential contamination.
Mobidiag stated that the system can be used in high-risk and difficult-to-reach locations without the requirement for highly trained personnel.
Mobidiag CEO Tuomas Tenkanen said: “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.”
The new test complements the Amplidiag COVID-19 diagnostic test
The new assay complements the Amplidiag Covid-19 emergency use test that was also launched this month and is suitable for high-throughput screening.
The test is currently being commercialised in Finland as an emergency use test. The company has also applied for emergency use authorisation of the test in Sweden, UK and France.
