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Mobidiag has received emergency use authorisation (EUA) in Finland for its Novodiag Covid-19 diagnostic test, which enables a rapid and fully automated detection of the SARS-CoV-2 virus that causes the Covid-19 infection.
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 allows a qualitative determination of SARS-CoV-2 orf1ab and N genes directly from nasopharyngeal swabs. It uses Novodiag rapid ‘sample-in, result-out’ system that supports fully automated detection of Covid-19 in one hour.
Furthermore, the closed system ensures the protection of laboratory staff and healthcare professionals from potential contamination.
Mobidiag said that the system can be used in high-risk and hard-to-reach locations without the need for highly trained personnel.
The company is currently seeking emergency use authorisation for the test in Sweden, the UK and France.
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 assay complements the Amplidiag Covid-19 emergency use test that was also launched this month and is suitable for high-throughput screening.
This test is currently available in Finland under EUA. It is routinely used in the main Finnish clinical laboratories and is being validated by the Pasteur Institute.