Lucira Health Announces U.S. Launch of First & Only At-Home Combination COVID-19 & Flu Test Amidst Sale Process

Rhea-AI Summary

Lucira Health has announced the launch of its COVID-19 & Flu Home Test in the U.S. and secured authorization for point-of-care use in Australia. This test, the first of its kind to receive emergency use authorization for at-home testing, provides lab-quality results for both COVID-19 and Flu from a single nasal swab within 30 minutes. Priced at $34.99, this breakthrough aims to facilitate timely treatment for patients experiencing similar symptoms. The company is also looking for strategic partnerships to enhance its product development and manufacturing capabilities.

Positive

• Launch of the COVID-19 & Flu Home Test in the U.S., the first at-home test of its kind.
• Test provides lab-quality results in 30 minutes, enabling timely treatment.
• Included in the Australian Register of Therapeutic Goods for point-of-care testing.
• Potential for market expansion in both U.S. and Australian markets.

Negative

• None.

Combination Test Also Secures Point-Of-Care Authorization in Australia

• Lab-quality results for both COVID-19 and Flu now available at home from one single test
• COVID-19 and Flu have similar symptoms but different treatments, requiring a fast, differential test to access time-sensitive prescription treatment options
• Lucira’s COVID-19 & Flu Home Test demonstrated similar performance for COVID-19 and Flu in head-to-head comparison study with highly sensitive lab-based PCR tests
• Lucira also secured point-of-care test (POCT) authorization in Australia prior to southern hemisphere flu season

EMERYVILLE, Calif., March 28, 2023 (GLOBE NEWSWIRE) -- Lucira Health, Inc. ("Lucira Health" or "Lucira"), a medical technology company, announced today both 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 and only 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-19 and Influenza compared to highly sensitive lab-based PCR tests in clinical trials. The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab, and as of today can be purchased in the United States for the introductory price of $34.99 at www.lucirahealth.com/flu.

“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,” said 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.”

“We are equally pleased to have our COVID-19 & Flu Test be included in the Australian Register of Therapeutic Goods. 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.”

For more information on the Lucira COVID-19 & Flu Home Test, please 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 (NAAT) test that utilizes the same platform and device design as both of Lucira's commercialized FDA authorized COVID-19 tests to provide independent diagnoses for COVID-19, Flu A and Flu B. The lab-quality single-use test fits in the palm of your hand, runs on 2 AA batteries, and with one shallow nasal swab provides a positive or negative result for COVID-19, Flu A and Flu B in 30 minutes or less. Each Lucira test contains everything needed to run a single test. There is no separate reader or instrument to purchase and maintain.

About Lucira Health
Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, lab-quality test results anywhere and at any time. Beyond its already commercialized molecular COVID-19 and COVID-19 & Flu tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women’s health and sexually transmitted infections (STIs). For more information, visit www.lucirahealth.com.

Forward Looking Statements
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 are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "can," “will,” “seek,” “believe,” “plans” and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, the ability of U.S. consumers to diagnose COVID-19 and Flu A or B while at home and get on the path to treatment and recovery within hours of receiving a test result; flu season typically picking up in the southern hemisphere as it quiets down in the United States; the Lucira COVID-19 & Flu Home Test’s ability to help patients quickly access treatment and recovery in Australia; Lucira’s seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products; and Lucira’s work on new diagnostic tests for respiratory infections, women’s health and STIs, are based upon Lucira’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and we assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Media Contact:
media@lucirahealth.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/5d194d4f-c3ad-4357-9177-d6bc5cb13021

https://www.globenewswire.com/NewsRoom/AttachmentNg/c81fc9fa-01a8-436b-820c-1f1dfd73cac7

https://www.globenewswire.com/NewsRoom/AttachmentNg/14978532-1d88-4b5d-8a5a-f81830559d37

FAQ

When was the Lucira COVID-19 & Flu Home Test launched in the U.S.?

The test was launched on March 28, 2023.

What is the purpose of the Lucira COVID-19 & Flu Home Test?

It provides lab-quality results for both COVID-19 and Flu from a single test at home.

What is the price of the Lucira COVID-19 & Flu Home Test?

The introductory price is $34.99.

Where has the Lucira test received point-of-care authorization?

It has been authorized for use in Australia.

Why is the Lucira test significant for consumers?

It allows consumers to diagnose COVID-19 and Flu A or B while at home, facilitating quicker access to treatment.