Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health” or “Lucira”), a medical technology company, announced today that the U.S. 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. 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. 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. Until today, American consumers have never before been able to self-diagnose Flu at home. The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab.

Lucira believes that a single test for both COVID-19 and Flu can be a powerful tool given how similar the two viruses appear. “COVID-19 and Flu look the same, feel the same, spread the same and, unfortunately, can still kill the same,” underscored Dr. Davey Smith, Head of the Division of Infectious Disease and Global Public Health at the University of California – San Diego. “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.”

“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. 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. “Many people are not aware that prescription antiviral medications exist for the treatment of Flu as well as for Covid. But we believe an accurate diagnosis, early in the course of infection is mandatory for effective use of such medications. 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.”

“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. Engelson. “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. 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. We remain confident in the role that the new test can play in future respiratory seasons and are honored to have received the first authorization for such a home test. We appreciate the diligent work of the FDA team as they refined requirements during the review cycle.”

Lucira is seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products.

The Company believes that its at-home, accurate diagnostic products are a critical third leg of the stool that also includes telehealth and home prescription delivery for the future of safe, home-based healthcare. Lucira’s expectation is that as accurate home diagnostics become prevalent, suffering and disease spread can be reduced, and that all constituents, including the public health, the healthcare value chain as well as the cost of healthcare can benefit. In the end, consumers may think of visiting a healthcare office for infectious disease diagnoses and treatment as being as antiquated as going to a video rental store to get a movie to watch: as a thing of the past.

Source: Company Press Release