US-based medical technology company Lucira Health has received the Health Canada authorisation for its at-home test for detection of Covid-19 and Influenza (Flu).
The Lucira Covid-19 & Flu Test is approved under Interim Order for emergency use and commercialisation in Canada.
It is a Nucleic Acid Amplification Tests (NAAT) that leverages the same platform and device design as the company’s independent tests for Covid-19, Flu A, and Flu B.
The single-use rapid molecular test is designed to fit in the palm, runs on two AA batteries, and uses a single shallow nasal swab.
It is a provides a positive or negative result for Covid-19, Influenza A (Flu A), and Influenza B (Flu B) with 99% accuracy, under 30 minutes, said the company.
Lucira said that it will prioritise the distribution of its Covid-19 & Flu Test in Canada, along with the current Covid-19 test.
Also, it will offer the test to institutions, agencies, and consumers prior to approaching fall and winter Covid and Flu season.
Lucira Health president and chief executive officer Erik Engelson said: “When influenza and Covid-19 co-circulate this winter, millions who don’t feel well will be asking ‘is it Covid-19 or flu?’ so they can take the appropriate action to get better.
“Only the Lucira Covid-19 & Flu Test, a single at-home test with 99% accuracy, can answer this question immediately.
“We appreciate Health Canada for its careful and thorough assessment of the Lucira Covid-19 & Flu Test. This timely action is expected to help Canadians accurately test at-home in advance of flu season, keep more people out of the emergency departments, and provide a rapid treatment pathway.”
Health Canada’s has granted the approval based on performance data reviewed under the agency’s expedited authorization pathway, Interim Order No. 3.
It has reviewed clinical data from both retrospective remnant samples and prospective clinical studies of the Lucira Covid-19 & Flu Test, compared to established PCR tests.
In both the studies a total of 677 samples were tested, with 425 samples in the retrospective remnant study and 252 subjects enrolled in the prospective study.
Lucira is a medical technology company focused on the development and commercialisation of innovative infectious disease tests to make lab-quality diagnostics more accessible.
