Lucira Health, Inc. (“Lucira Health” or “Lucira”) (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, announced that preliminary clinical study results for its COVID-19 & Flu test demonstrated similar sensitivity and specificity to highly sensitive lab-based PCR assays for COVID-19, Flu A, and Flu B.
“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, principal investigator for the recently concluded study at Sutter Health in California. “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 antiviral treatments 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.”
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 a 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 samples from 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 on the comparator lab PCR assay.