NEW YORK ─ Mobidiag said Wednesday it has received Emergency Use Authorization in Finland for its Novodiag COVID-19 diagnostic test for the rapid and fully automated detection of the SARS-CoV-2 virus.
The Espoo, Finland-based firm said it is also seeking Emergency Use Authorization for the test in Sweden, the United Kingdom, and France.
The Novodiag COVID-19 real-time PCR assay enables on-demand detection of early COVID-19 infections in about one hour, allowing for rapid isolation and treatment guidance, Mobidiag said.
The test detects SARS-CoV-2 orf1ab and N genes directly from nasopharyngeal swabs and runs on the Novodiag closed system, which ensures the protection of laboratory staff and healthcare professionals from possible contamination, the firm said. The system can be used in high-risk and difficult-to-reach areas without the need for highly trained personnel, it added.
The company said that its Novodiag test complements its Amplidiag COVID-19 test, which is suitable for high-throughput screening, and was launched with Emergency Use Authorization for Finland on April 14.
Amplidiag is routinely used in the main Finnish clinical laboratories and is being validated by the Institut Pasteur National Reference Center in France.