NEW YORK – Mobidiag said Tuesday it has received Emergency Use Authorization in Finland for its Amplidiag COVID-19 real-time PCR test for the rapid detection of SARS-CoV-2, enabling its use in Finland.
The main clinical laboratories in Finland ─ Helsinki University Hospital, Synlab, and Mehiläinen ─ will use the assay for routine testing, doubling Finnish testing capacity and allowing coverage for most of the country, Mobidiag said.
Its assay allows for the qualitative determination of SARS-CoV-2 orf1ab and N genes from nasopharyngeal swabs. Tests are run on Mobidiag’s Amplidiag Easy high-throughput PCR platform, which enables clinicians to do optimized sample screening with automated DNA extraction and PCR plate setup. The platform can process 48 samples in less than three hours and has the capacity to test up to 4,000 samples per day, Mobidiag said.
Further, the company is developing Novodiag COVID-19, a molecular diagnostic test that uses the firm's Novodiag system for the rapid and on-demand detection of SARS-CoV-2. That test will complement Amplidiag COVID-19 in enabling clinicians to detect SARS-CoV-2 infections early, support decisions in efficiently managing epidemiological and infection-control measures, and facilitate the isolation of infected patients in a timely manner, the company said.
Tuomas Tenkanen, CEO of Mobidiag, said in a statement that the company anticipates offering tests "internationally in due course."
Espoo, Finland-based Mobidiag said it will register its test for the CE-IVD mark and is in the process of seeking EUA in Sweden, the UK, and France. The Amplidiag COVID-19 test should be available for widespread use in Europe in the coming weeks, it said.