EMERYVILLE, Calif. – August 11, 2022 – 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.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “can,” “will,” “expect,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, statements regarding the distribution of the COVID-19 & Flu Tests in Canada, the upcoming winter respiratory disease season in Canada, accuracy of our COVID-19 & Flu Test, the demand of our COVID-19 & Flu Test by Canadian consumers, ; are based upon Lucira’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including our ability to increase production, streamline operations and increase product availability; the success of our test platform with COVID-19 including its variants, the extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 and influenza test kits; our expected future growth; our ability to obtain and maintain regulatory approval for our test kits, including our existing Emergency Use Authorization for our COVID-19 and influenza test kits and LUCI Pass; the size and growth potential of the markets for our test kits, including the COVID-19 and influenza diagnostic testing market, and our ability to serve those markets; our ability to accurately forecast demand for our test kits; the rate and degree of physician and market acceptance of our test kits; the expected future growth of our sales and marketing organization; coverage and reimbursement for our test kits; the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc. and our single-source suppliers; our ability to accurately forecast, and Jabil’s ability to manufacture, appropriate quantities of our COVID-19 and influenza test kits to meet commercial demand; regulatory developments in the United States and foreign countries; our research and development for any future test kits; the development, regulatory approval, and commercialization of competing products; our ability to retain and hire senior management and key personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; our expectations regarding our ability to obtain and maintain intellectual property protection for our test kits, as well as our ability to operate our business without infringing the intellectual property rights of others; and our ability to navigate unfavorable global economic conditions that may result from recent geopolitical events, including the COVID-19 pandemic, Russia’s military intervention in Ukraine, and the global sanctions imposed by countries against Russia that followed. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.
Lucira Health announced today both the nationwide launch of its breakthrough Lucira COVID-19 & Flu Home Test in the United States, as well as the combination test’s inclusion in the Australian Register of Therapeutic Goods (ARTG) for use by healthcare professionals in a point-of-care setting
With 99% accuracy and within 30 minutes, institutions will simultaneously and accurately test residents, health workers and visitors for COVID-19 and Flu A/B
Lucira’s COVID-19 & Flu Test performed comparably in a head-to-head comparison study with highly sensitive lab-based PCR tests