Lucira Health, a medical technology company, announced the nationwide launch of its breakthrough Lucira COVID-19 & Flu Home Test in the United States, as well as the combination test’s inclusion in the Australian Register of Therapeutic Goods (ARTG) for use by healthcare professionals in a point-of-care setting.
The COVID-19 & Flu Home Test is the first combination COVID-19 & Flu test to be granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) 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 and Influenza compared to highly sensitive lab-based PCR tests in clinical trials.
“Both of these accomplishments represent important milestones for Lucira and underscore the viability of the Lucira technology platform in both at-home and point-of-care settings around the globe,” says Erik Engelson, president and CEO of Lucira Health. “U.S. consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home. With one-touch access to telehealth via our Lucira Connect web platform, they can now get onto the path to treatment and recovery within hours of receiving a test result from the comfort of home.”
The all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab, and can now be purchased in the United States.
“We are equally pleased to have our COVID-19 & Flu Test be included in the Australian Register of Therapeutic Goods,” says Engelson. “When flu season quiets down in the United States, it typically picks up in the southern hemisphere, and we believe that the speed and accuracy of diagnosis from our combination test could help patients to quickly access treatment and recovery in Australia. These authorizations speak to the future and clinical relevance of Lucira products as we seek a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products.”
Featured image: The Lucira COVID-19 & Flu Home Test. Photo: Lucira