NEW YORK – South Korean molecular diagnostic company Seegene announced on Monday that its Allplex SARS-CoV-2/FluA/FluB/RSV Assay has received approval under Health Canada's Interim Order.
The multiplex real-time PCR test enables simultaneous amplification and differentiation of respiratory symptoms, distinguishing between SARS-CoV-2, influenza A/B, and respiratory syncytial virus.
Seegene said in a statement that it delivered 340,000 COVID-19 tests to Canada last week to help with the growing surge in the country. The Health Canada approval is "expected to be a significant opportunity for the company," it said, allowing the firm to raise awareness of its products in surrounding countries, such as Latin America.
"Demand for COVID-19 tests is skyrocketing due to the resurgence of confirmed cases," Ho Yi, chief sales and marketing officer at Seegene, said in a statement. "We are fully prepared to supply enough test kits globally and will continue to be strong global partners in the effort to manage the spread of COVID-19."
Health Canada's Interim Order allows the Department of Health to issue expedited authorizations for the sale or import of medical devices to deal with the risk of COVID-19.