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Mobidiag Receives CE Mark for Two PCR SARS-CoV-2 Tests

NEW YORK – Finnish molecular diagnostics firm Mobidiag said on Tuesday that its Novodiag COVID-19 and Amplidiag COVID-19 PCR tests have received CE-IVD marking.

The Novodiag COVID-19 test uses nasopharyngeal swabs to detect the SARS-CoV-2 orf1ab and N genes and runs on Mobidiag's Novodiag rapid fully automated system, providing results in an hour. The company noted that its platform is user friendly and closed, which means it can protect users from contamination and can be used in decentralized areas.

The company's real-time PCR Amplidiag COVID-19 test complements the Novodiag test, running on the Amplidiag Easy platform and processing 48 samples in less than three hours. The Novodiag and Amplidiag tests have received Emergency Use Authorization in Finland, Sweden, and France, Mobidiag said in a statement.

Supply chain issues have contributed to the difficulty in ramping up testing capacity, and Mobidiag said it has sourced and acquired various consumables to cover the complete workflow of the tests from sample collection to results. It is producing enzymes in house and has developed proprietary mNAT Medium sample buffer and collection tubes, the firm added. 

Espoo, Finland-based Mobidiag already offers an antibody test, Anti-SARS-CoV-2 Rapid Test, that it is distributing for Autobio Diagnostics, its joint venture partner in China. The test determines the presence of IgG and IgM antibodies in human serum, plasma, or whole blood in less than 15 minutes.