Combination test also secures point-of-care approval in Australia
- Lab-quality results for COVID-19 and flu are now available at home with a single test
- COVID-19 and influenza have similar symptoms but different treatments that require rapid differential testing to gain access to time-sensitive prescription treatment options
- Lucira’s COVID-19 and Flu Home Test demonstrated similar performance for COVID-19 and flu in a head-to-head comparison study with highly sensitive laboratory-based PCR tests
- Lucira also secured point-of-care testing (POCT) approval in Australia ahead of the start of the southern hemisphere flu season
EMERYVILLE, Calif., March 28, 2023 (GLOBE NEWSWIRE) — Lucira Health, Inc. (“Lucira Health” or “Lucira”), a medical technology company, today announced both the nationwide launch of its breakthrough Lucira COVID-19 & Flu home test in the United States and the inclusion of the combination test in the Australian Registry of Therapeutic Goods (ARTG) for use by healthcare professionals in a point-of-care setting. The COVID-19 & Flu Home Test is the first and only combined COVID-19 & Flu test to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) use at home and in an emergency, other non-laboratory locations were granted. The Lucira COVID-19 & Flu Home Test is a molecular test that demonstrated similar performance for COVID-19 and influenza when compared to highly sensitive laboratory-based PCR tests in clinical trials. The easy-to-use, all-in-one combo test provides results in 30 minutes or less with a flat nasal swab and is available today in the United States at an introductory price of $34.99 at www.lucirahealth.com/flu.
“Both achievements represent important milestones for Lucira and underscore the viability of Lucira’s technology platform in both the home and point-of-care settings around the world,” said Erik Engelson, President and CEO of Lucira Health. “US consumers will, for the first time ever, be able to diagnose at home whether they have COVID-19 or flu A or B. With one-touch access to telemedicine via our Lucira Connect web platform, they can now be on their way to treatment and recovery from the comfort of their own home within hours of receiving a test result.”
“We are also pleased that our COVID-19 and flu test has been included in the Australian Register of Therapeutic Goods. When influenza season calms down in the United States, it typically resumes in the Southern Hemisphere, and we believe the speed and accuracy of our combination test’s diagnosis could help patients access treatment and recovery quickly in Australia. These approvals speak to the future and clinical relevance of Lucira products as we seek a strategic or financial partner to resume manufacturing and development of additional home diagnostic products.”
For more information on the Lucira COVID-19 & Flu Home Test, visit www.lucirahealth.com/flu.
About the Lucira COVID-19 & Flu Home Test
The Lucira COVID-19 & Flu Home Test is not an antigen test. It is a molecular nucleic acid amplification test (NAAT) that uses the same platform and device design as Lucira’s two commercialized, FDA-cleared COVID-19 tests to provide independent diagnoses for COVID-19, influenza A, and deliver influenza B. The lab-quality single-use test fits in the palm of your hand, runs on 2 AA batteries, and provides a positive or negative result for COVID-19, Flu A, and Flu B in 30 minutes or less with a flat nasal swab. Every Lucira test has it all , which is required to run a single test. There is no need to purchase and maintain a separate reader or instrument.
About Lucira Health
Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make laboratory quality diagnostics more accessible. Lucira has designed its testing platform to deliver accurate, reliable, lab-quality testing results anywhere, anytime. In addition to its already commercialized COVID-19 and COVID-19 and flu molecular tests, Lucira is working on new diagnostic tests for respiratory infections and other categories, including women’s health and sexually transmitted infections (STIs). Visit www.lucirahealth.com for more information.
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 involve risks and uncertainties, actual results could differ materially from those indicated by such forward-looking statements expressed or implied. Words such as “may”, “will”, “aim”, “believe”, “plan” and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, the ability of US consumers to diagnose COVID-19 and flu A or B at home and begin their journey to treatment and recovery within hours of receiving a test result; Flu season typically kicks in in the Southern Hemisphere while calming down in the United States; the ability of the Lucira COVID-19 & Flu Home Test to provide patients in Australia with rapid access to treatment and recovery; Lucira is seeking a strategic or financial partner to resume manufacturing and development of additional home diagnostic products; and Lucira’s work on new diagnostic tests for respiratory infections, women’s health and sexually transmitted diseases is based on Lucira’s current expectations and involves assumptions that may never come to pass or prove incorrect. Actual results could differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties. Any forward-looking statements we make in this release speak only as of the date of this press release, and we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise after the date of this press release, if so not required by applicable law.
Photos accompanying this announcement are available at
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