Under an interim order, Health Canada has authorized the emergency use and commercialization of the Lucira Health at-home COVID-19 & Flu test, the firm said this week.
The company said the rapid molecular test, which delivers results in 30 minutes or less from a shallow nasal swab, is available to institutions, agencies, and consumers in advance of the approaching fall and winter COVID-19 and flu season.
Health Canada's decision was based on performance data for the test reviewed under the organization's expedited authorization pathway, Lucira said.
A combined total of 677 samples were tested in studies, of which 425 samples were included in a retrospective remnant study and an additional 252 subjects enrolled in the prospective study.
