TORONTO – COVID-19 Update – Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health,” “Lucira” or the “Company”), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, today announced that Health Canada has granted Authorization under Interim Order for the emergency use and commercialization of the first and only at-home test for COVID & Flu. The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab.
Distribution of the COVID-19 & Flu Test in Canada will be prioritized along with the current COVID-19 Test and is available to institutions, agencies, and consumers in advance of the approaching fall and winter COVID and Flu season. Lucira’s COVID-19 & Flu Test is available now for online ordering at: www.lucirahealth.ca.
“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,” said Erik Engelson, President and Chief Executive Officer of Lucira Health. “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 decision is based on performance data reviewed under Health Canada’s expedited authorization pathway, Interim Order No. 3. As a part of the authorization process, clinical data gathered from both retrospective remnant samples and prospective clinical studies were included in support of the Lucira COVID-19 & Flu Test performance against recognized PCR Lab based tests. A combined total of 677 samples were tested across both studies, of which 425 samples were included in the Retrospective Remnant Study and an additional 252 subjects enrolled in the Prospective Study.
About Lucira COVID-19 & Flu Test
The Lucira COVID-19 & Flu Test is a NAAT test utilizing the same platform and device design as Lucira’s COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B. The single-use test fits in the palm of your hand, runs on two AA batteries, and with one nasal swab, provides a positive or negative result for COVID-19, Flu A, and Flu B in 30 minutes or less. Each Lucira test is packaged with everything needed to run a single test: the test device, two AA batteries, sample vial, swab, and simple instructions. There is no separate reader or instrument to purchase and maintain.
About Lucira Health
Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Beyond its already commercialized COVID-19 and COVID-19 & Flu Tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women’s health and sexually transmitted infections (STIs). For more information, visit www.lucirahealth.com.