Lucira nabs Canadian go-ahead for COVID-19/Flu MDx test

2020 05 11 23 50 9621 Lab 2019 Coronavirus Test 400

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.

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