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Coronavirus Tests From Seegene, DiaSorin, Others Get Health Canada Approval

NEW YORK – Health Canada recently approved tests for SARS-CoV-2, the virus that causes COVID-19, permitting their marketing and use in that country. Recent approvals include the Seegene Allplex 2019-nCoV and DiaSorin Molecular Simplexa COVID-19 Direct, both of which are real-time RT-PCR assays.

Seegene said Monday that the Health Canada approval will enable Canadian hospitals and licensed labs to run the assay immediately for high-volume testing. The South Korea-based firm said its SARS-CoV-2 assay is already being used in more than 40 countries, and that it is manufacturing and delivering more than 3 million of the tests per week globally.

On Thursday last week, the day it granted approval to Seegene, Health Canada also gave the nod to DiaSorin Molecular for use of its nasopharyngeal swab-based Simplexa COVID-19 Direct assay, running on its sample-to-answer Liason MDX real-time PCR instrument. Last month, the firm received US Food and Drug Administration Emergency Use Authorization for the assay.

Health Canada has also recently given approvals for the Roche Cobas SARS-CoV-2 assay, Abbott Realtime SARS-COV-2 assay, Luminex NxTag COV Extended Panel, PerkinElmer New Coronavirus Nucleic Acid Detection Kit, 1Drop 1copy COVID-19 qPCR Multi Kit, SolGent DiaPlexQ Novel Coronavirus Detection Kit (2019-nCoV), Quidel Lyra SARS-CoV-2 Assay, and Hologic SARS-CoV-2 Assay.