Seegene Receives Health Canada Approval for its COVID-19 Assay

Seegene, Inc. announced that Health Canada (HC) authorized an interim order which allows the import and sale in Canada of Seegene's Allplex™ 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel coronavirus responsible for the COVID-19 disease.

The government of Canada is reporting there are now 20,748 confirmed cases of COVID-19 and 509 deaths in Canada on April 9, 2020 according to Public Health Information System. Seegene anticipates that the Health Canada approval will now enable laboratories in Canada to run Seegene's test immediately for high-volume testing.

Seegene's test is being used in over 40 countries as the global standard SARS-CoV-2 test, including in countries with the most active testing such as Italy, Spain, France, Germany and many other countries. Seegene is currently manufacturing and delivering over 3 million tests per week globally. The immediate adoption of the Seegene Assay in many countries was possible due to its extensive laboratory network around the globe and its well-established reputation of being the leading developer of syndromic disease testing with the broadest test menu.

Seegene Canada, based in Toronto, provides large hospitals and private labs across Canada with lab solutions for automated molecular diagnostics. Most recently, Seegene Canada partnered with the Provincial Public Health Lab in St. John's, NL to provide a significant increase in their SARS-CoV-2 testing capacity. Until now Seegene reagents were only available for "research use only", but with this announcement Hospitals and licensed labs are now allowed to use the test outside of research settings.

"We feel that it is our duty to help the society with our technologies in this time of need. We are incredibly proud to be providing the Seegene Assay which represents the leading edge of testing technologies. We will continue to stay prepared for any modifications required to ensure the most accurate detection of the mutative SARS-CoV-2," said Dr. Jong-Yoon Chun, CEO of Seegene.

About Seegene

Seegene (KQ: 096530) is the world's leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx). Seegene's core enabling technologies - DPO™, TOCE™, and MuDT™ - are the foundation for M-MoDx tests that can simultaneously detect multiple targets with high sensitivity, specificity and reproducibility. Seegene's products detect multi-pathogens with great reliability and throughput, ultimately providing the most economical basis for saving time, labor and cost. Seegene's mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics, and oncology using innovative proprietary technologies.

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