Mobidiag’s COVID-19 test okayed for emergency use

Mobidiag Ltd.’s Amplidiag^® COVID-19 PCR test will double Finnish testing capacity and allowing testing coverage for most of the country. The rapid for the detectionof the SARS-CoV-2 virus, however is no point-of-care test but will be run at the main clinical laboratories in Finland, Helsinki University Hospital (Huslab), SYNLAB and Mehiläinen. The company has also applied for emergency use authorization  in Sweden, UK and France, where the Espoo-based company has subsidiaries.

Mobidiag announced it will register the PCR test for CE-IVD mark and will organise sales through teams and local distributors.

The assay allows qualitative determination of SARS-CoV-2 (orf1ab and N genes) from nasopharyngeal swabs. The test runs on Mobidiag’s Amplidiag^® Easy platform, which was developed in collaboration with automation specialist Tecan and which enables an optimized sample screening process with automated DNA extraction and PCR plate setup.