Health Canada Updates COVID-19 Test Review Priorities

May 18, 2021

Health Canada has revised its priorities for reviewing COVID-19 test applications and is now giving top priority to self-testing devices and point-of-care antigen or molecular tests administered by trained operators rather than healthcare professionals.

The agency is also giving priority to tests for emerging SARS-CoV-2 variants, to those that offer new or unique advantages compared to other tests of the same type, and to novel diagnostic technologies that may use alternative samples, such as breath, or a different analytical approach.

Given the number of COVID-19 tests already authorized, lab-based molecular tests that don’t use saliva samples or offer new or unique advantages, point-of-care tests that use only nasopharyngeal swab samples, and lab-based and point-of-care serology tests are now less of a priority, the agency said.

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