Lucira Receives CE Mark for both COVID-19 & Flu and COVID-19 Molecular Tests
EMERYVILLE, Calif., May 09, 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 that both its COVID-19 & Flu and COVID-19 molecular tests have received CE Mark for professional use, clearing both tests for sale and distribution throughout the European Union.
The Lucira COVID-19 & Flu and COVID-19 tests are Nucleic Acid Amplification Tests (NAAT) with sensitivity and specificity comparable to lab-based PCR assays, miniaturized to run on a palm-sized device with no separate instrument or reader, producing results in 30 minutes. Lucira's COVID-19 test is currently available in the US, Canada, Singapore, Israel, and Taiwan with millions of tests distributed to date. 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 with results in less than 30 minutes.
"The Lucira testing platform can make highly accurate molecular point-of-care testing more accessible than previously possible with our simple test that requires no separate instrument or reader, internet connection, or power cord," said Erik Engelson, the President and CEO of Lucira Health. "Receiving CE Mark for both our COVID-19 & Flu and COVID-19 tests represents a major milestone for Lucira to expand our product-line and our geographic reach."
COVID-19 and flu have similar symptoms but distinct treatments, making tests to differentiate between these infections crucial when the viruses that cause them are both in circulation. Lucira plans to make its COVID-19 & Flu test available in the European Union beginning in the third quarter of 2022 in advance of the Northern Hemisphere influenza season.
Clinical trial results with the Lucira COVID-19 & Flu test were positive and submissions to other regulatory authorities, including the U.S. Food & Drug Administration and Health Canada, are planned for the second quarter of 2022 with decisions expected before this upcoming flu season.
About the Lucira COVID-19 Test
The Lucira COVID-19 test is a Nucleic-Acid Amplification Test (NAAT). The test fits in the palm of your hand, extracts genetic material from the virus and amplifies it, similar to PCR lab tests, to detect the presence of virus earlier and more accurately than antigen tests. There is no additional equipment to purchase, such as a reader or instrument. 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.
About the Lucira COVID-19 & Flu Test
The Lucira COVID-19 & Flu test is a molecular 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 result for COVID-19, Flu A, and Flu B in less than 30 minutes.
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, easy-to-use, 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.
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," "may," "anticipates," "expects," and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding, among others, Lucira's planned regulatory submissions of its COVID-19 and Flu test to other regulatory authorities and the timing and availability of Lucira's COVID-19 & Flu test available throughout the European Union. 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.
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