“These data for Lucira’s COVID-19 & Flu test are very important because they demonstrate that the ability to put the sensitivity and specificity of lab-based PCR assays in the palm of your hand at home can extend beyond COVID-19 into other serious infectious diseases,” said Dr. John Chou of Sutter Health and Primary Investigator for the study. “As the COVID-19 pandemic evolves, so does our primary reason for testing. The shift from test-to-isolate to test-to-treat will require availability of fast, accurate, and accessible diagnostic tools for multiple infectious diseases.”
While COVID-19 testing has become commonplace during the pandemic, flu testing is done less frequently, and no at-home self-test for flu has ever been available, despite annual widespread outbreaks. COVID-19 and flu both have multiple FDA authorized or approved antivirals that are reported to be most effective when taken early in the course of disease.
“As masks come off and social distancing relaxes, it becomes more likely that we will experience a return of influenza outbreaks along with COVID-19 circulation this fall and winter,” said Debkishore Mitra, CTO and co-founder of Lucira Health. “When you experience influenza-like-illness, it’s going to be critical to quickly understand which infection you have, so you can get the right treatment and start it early in the disease course. We are optimistic that our at-home COVID-19 & Flu test can enable that to happen for millions around the world.”
Regulatory submissions to the U.S. Food & Drug Administration, Health Canada, European Medicines Agency, and other regulatory authorities are planned for the second quarter of 2022 with decisions expected before this upcoming flu season.
About the Lucira COVID-19 & Flu Test
The Lucira COVID-19 & Flu test is an investigational molecular at-home test utilizing the same platform and device design as Lucira’s COVID-19 tests 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 2 AA batteries, and with one nasal swab provides a positive or negative diagnosis for COVID-19, Flu A, and Flu B in less than 30 minutes.
About the Clinical Study
The Lucira Covid-19 & Flu test is being evaluated in over 600 subjects at multiple sites in California and Texas, comparing its ability to accurately detect COVID-19, Flu A, and Flu B to highly sensitive lab-based emergency use authorized COVID-19 and 510k approved flu PCR assays. The study includes retrospective and prospective arms in which subjects’ samples are tested on the Lucira device and have another sample run on the comparator lab PCR assay.
About Lucira Health
Lucira is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests. Lucira’s testing platform produces lab quality molecular testing in a single-use, consumer-friendly, palm-size test kit powered by two AA batteries. Lucira designed its test kits to provide accurate, reliable, and on-the-spot molecular test results anywhere and at any time.
Beyond its COVID-19 tests, Lucira is working on new diagnostic tests including a single test for COVID-19 & Flu as well as other infectious diseases. 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,” “plans,” “will,” “may,” “anticipates,” “expects,” “potential,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements 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 Lucira’s ability to increase production, streamline operations and increase product availability; the success of Lucira’s test platform with COVID-19 including its variants, flu A and flu B; the extent and duration of the COVID-19 pandemic and Lucira’s expectations regarding customer and user demand for its COVID-19 test kit and the candidate COVID-19 and flu test kit; Lucira’s ability to obtain and maintain regulatory approval for its test kits, including Lucira’s existing Emergency Use Authorization for its COVID-19 test kits and LUCI Pass; Lucira’s expectations around the timing of submission and receipt of regulatory approval for its test kits; the performance of, and Lucira’s reliance on, third parties in connection with the commercialization of its test kits, including Jabil Inc., Switch Health and Lucira’s single-source suppliers; Lucira’s ability to successfully continue to expand internationally; any impact on Lucira’s ability to market its products; demand for Lucira’s products due to deferral of procedures using its products or disruption in its supply chain; Lucira’s ability to achieve or sustain profitability; Lucira’s ability to gain market acceptance for its products and to accurately forecast and meet customer demand; Lucira’s ability to compete successfully; Lucira’s ability to enhance and expand its product offerings, including its candidate COVID-19 and flu test kit; Lucira’s ability to accurately predict continued expansion; Lucira’s ability to accurately forecast revenue; development and manufacturing problems; capacity constraints or delays in production of Lucira’s products; maintenance of coverage and adequate reimbursement for procedures using Lucira’s products; and product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in Lucira’s filings with the Securities and Exchange Commission and available at www.sec.gov, including in its 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.