12/8/2023 0 Comments Bridge diagnostics covid results![]() The Lucira COVID-19 & Flu Home Test would have been especially useful during the recent, severe respiratory season, and we had produced inventory for an anticipated autumn 2022 launch. “Unfortunately we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through, despite working closely with FDA. “We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization,” added Mr. Prescription and fulfillment over telehealth is convenient and safe, especially when at-home diagnoses take place using a test such as the Lucira COVID-19 & Flu Home Test.” But we believe an accurate diagnosis, early in the course of infection is mandatory for effective use of such medications. “Many people are not aware that prescription antiviral medications exist for the treatment of Flu as well as for Covid. The authorization of the COVID-19 & Flu Home Test with OTC label is another example of how Lucira is helping to transform the future promise of home-based, fast, accurate diagnostics into a reality,” said Erik Engelson, President and CEO of Lucira Health. ![]() ![]() “Our small but experienced team at Lucira has again demonstrated the versatility of our technology platform by introducing this first-of-its-kind innovation in clinically relevant at-home diagnostics to the marketplace. “Having an at-home molecular test now available should really help people know how to keep their families safe and seek appropriate treatment when they're ill.” Davey Smith, Head of the Division of Infectious Disease and Global Public Health at the University of California – San Diego. “COVID-19 and Flu look the same, feel the same, spread the same and, unfortunately, can still kill the same,” underscored Dr. Lucira believes that a single test for both COVID-19 and Flu can be a powerful tool given how similar the two viruses appear. The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab. Until today, American consumers have never before been able to self-diagnose Flu at home. Lucira’s COVID-19 & Flu Home Test represents a breakthrough in diagnostic testing as the first at-home combination COVID-19 and Flu test, and as the first Flu test for OTC use at home in the United States in history. The Lucira COVID-19 & Flu Home Test is a molecular test that demonstrated similar performance for COVID-19 and Influenza A and B compared to highly sensitive lab-based PCR tests in clinical trials. ![]() Food and Drug Administration (FDA) granted emergency use authorization (EUA) for its Lucira COVID-19 & Flu Home Test for over the counter (OTC) use at home and other non-laboratory sites. (Nasdaq: LHDX) ("Lucira Health" or "Lucira"), a medical technology company, announced today that the U.S. 27, 2023 (GLOBE NEWSWIRE) - Lucira Health, Inc.
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