Lucira Files for Authorization of First-of-its-Kind COVID-19 & Flu At-Home Molecular Test
This first ever at-home COVID-19 and flu test is designed to allow individuals to differentiate between the infections and seek appropriate treatment within 30 minutes from home
EMERYVILLE, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. ("Lucira Health" or "Lucira") (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of innovative infectious disease tests, announced today that it has submitted a request to the U.S. Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 & Flu test. The request is for prescription at-home use of the PCR-quality test for those with suspected COVID-19 or Influenza. Lucira is seeking FDA authorization before this upcoming fall and winter, when SARS-CoV-2 and influenza viruses are likely to co-circulate.
"We are very proud to have reached this important milestone toward introducing the first at-home COVID-19 & Flu test," said Erik Engelson, President and CEO of Lucira Health. "Lucira was founded to make lab-quality diagnostics more accessible to give people who get sick a faster, cheaper, and easier path to treatment. In this phase of the pandemic, with life-saving antivirals available and less restrictions leading to the reemergence of other respiratory viruses, we believe delivering a highly accurate at-home test for both COVID-19 and flu can greatly improve access to appropriate therapeutics in the window of time when they are most effective."
The Lucira testing platform is a Nucleic Acid Amplification Test (NAAT) with sensitivity and specificity comparable to lab-based PCR assays, miniaturized to run on a palm-sized device with no separate instrument, producing results within 30 minutes. Lucira's standalone COVID-19 test was the first at-home COVID-19 test to receive an EUA from the FDA in November 2020. The Lucira COVID-19 & Flu test uses the same platform and palm-sized device design and independently tests for COVID-19, Flu A, and Flu B from a single nasal swab.
Clinical trial results with the Lucira COVID-19 & Flu test were positive, demonstrating comparable sensitivity and specificity to leading lab-based PCR assays. The test recently received CE Mark and submissions to other regulatory authorities are in progress.
About the 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 commercialized EUA authorized 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 result for COVID-19, Flu A, and Flu B in less than 30 minutes. Each Lucira test contains everything needed to run a single COVID-19 test: the test device, two AA batteries, sample vial, swab, and simple instructions. There is no separate reader or instrument to purchase and maintain. Lucira is seeking an EUA for prescription at-home use of the test.
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 tests, Lucira is working on new diagnostic tests including a single test for COVID-19 & Flu, additional respiratory infections, and for other categories including Sexually Transmitted Infections (STIs). For more information, visit www.lucirahealth.com.
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," "seek,” "toward," "plans," "may," "anticipates," "expects," and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding, among others, the timing and availability, if approved, of Lucira's COVID-19 & Flu test available throughout the United States. 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 and the COVID-19 and Flu test; Lucira's ability to obtain and maintain regulatory approval for its tests, including Lucira's existing Emergency Use Authorization for its COVID-19 test and LUCI Pass; Lucira's expectations around the timing of submission and receipt of regulatory approval for its tests; the performance of, and Lucira's reliance on, third parties in connection with the commercialization of its tests, 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 tests; demand for Lucira's tests due to deferral of procedures using its tests or disruption in its supply chain; Lucira's ability to achieve or sustain profitability; Lucira's ability to gain market acceptance for its tests and to accurately forecast and meet customer demand; Lucira's ability to compete successfully; Lucira's ability to enhance and expand its product offerings; 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 tests; maintenance of coverage and adequate reimbursement for procedures using Lucira's tests; and test 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 subsequently filed reports. Any forward-looking statements that Lucira makes 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.