Lucira Health Announces FDA Authorization of Combination COVID-19 & Flu Test at Point-of-Care

Rhea-AI Summary

Lucira Health has received emergency use authorization (EUA) from the FDA for its COVID-19 & Flu Test, which provides PCR-quality results in 30 minutes or less from a single nasal swab. The test can yield a positive result in just 11 minutes and can be used in CLIA-waived settings, facilitating rapid diagnoses amidst co-circulating respiratory viruses. This test aligns with Lucira's mission to enhance accessibility to high-quality diagnostics.

Positive

• FDA granted EUA for COVID-19 & Flu Test, enabling rapid diagnosis.
• Test delivers results in 11 to 30 minutes from one nasal swab.
• No need for capital investment in equipment; can be used in CLIA-waived settings.

Negative

• None.

PCR-Quality Accuracy with Results in 30 Minutes or Less, Just in Time for Flu Season

• PCR Lab-quality NAAT/molecular test for both COVID-19 and flu from 1 shallow nasal swab
• Positive result as quickly as 11 minutes, negative result in 30 minutes, allowing diagnosis during patient visit
• Equipment-free Lucira platform requires no capital investment or calibration and permits unlimited simultaneous testing
• 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 Test performed comparably in a head-to-head comparison study with highly sensitive lab-based PCR tests

EMERYVILLE, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- 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 Test, for point-of-care use. The Lucira COVID-19 & Flu Test is a molecular test that performed comparably to highly sensitive lab-based PCR assays in clinical trials. This combination test is the first in a pipeline of other multiple assay tests that leverage Lucira technology platform’s ability to multiplex from a single sample. The easy-to-use test delivers results between 11 and 30 minutes from one shallow nasal swab. The Lucira COVID-19 & Flu Test is available for use in CLIA-waived settings and can be purchased online at: www.lucirahealth.com, or email sales@lucirahealth.com for bulk orders.

“The Northern Hemisphere is already experiencing a challenging season due to the unprecedented co-circulation of COVID-19, flu and RSV. COVID-19 and flu viruses can both cause serious illness with similar symptoms, but each has unique prescription treatments that require diagnosis early in the infection to be effective. The inaccuracy of antigen COVID-19 tests makes such tests inadequate to use for early differential diagnosis of flu versus COVID-19. Clinicians can now facilitate simultaneous rapid testing at a mass scale to get patients on the path to recovery quickly,” said Erik Engelson, President and CEO of Lucira Health. “With this test and future testing capabilities, we aim to be at the forefront of quality, at-home health management.”

For more information on Lucira COVID-19 & Flu Test, visit www.lucirahealth.com.

About the Lucira COVID-19 & Flu Test
The Lucira COVID-19 & Flu Test is a NAAT test utilizes the same platform and device design as Lucira's commercialized FDA authorized COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B. The PCR-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, PCR-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, 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,” “expected,” “allow,” “aim” and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, statements regarding the accuracy of our COVID-19 test; the timing of results from the Lucira COVID-19 & Flu Test multi-center study designed to enable at-home over-the-counter use of the test; Northern Hemisphere experiencing a challenging season due to the unprecedented co-circulation of COVID-19, flu and RSV; COVID-19 and flu viruses causing serious illness with very similar symptoms; clinicians facilitating mass testing at a rapid scale to get patients on the path to recovery quickly, are based upon our 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. These risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and subsequently filed reports. 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 Contacts:
Mike Stommel
Lucira@luckybreakpr.com
323-333-2901

Investor Contact
Greg Chodaczek
Investorrelations@lucirahealth.com
332-895-3230

Photos accompanying this announcement are available at: 

https://www.globenewswire.com/NewsRoom/AttachmentNg/33a8ad74-1a73-4946-8dab-d2ad79032d34

https://www.globenewswire.com/NewsRoom/AttachmentNg/a7e5b9cb-8017-4ff5-b9d3-e9dd96bde05c

https://www.globenewswire.com/NewsRoom/AttachmentNg/3c382671-0c79-4a6f-a9f9-95e6e247b700

FAQ

What is the Lucira COVID-19 & Flu Test approved by the FDA?

The Lucira COVID-19 & Flu Test is a molecular test that provides results for COVID-19 and flu from a single nasal swab within 30 minutes.

How quickly can the Lucira COVID-19 & Flu Test deliver results?

The Lucira test can provide a positive result in as little as 11 minutes, with negative results available in 30 minutes.

What are the benefits of the Lucira COVID-19 & Flu Test?

The test allows for rapid diagnosis, requires no capital investment in equipment, and can be used in various healthcare settings.

What is the stock symbol of Lucira Health?

Lucira Health's stock symbol is LHDX.

What is the significance of the EUA for Lucira Health's stock LHDX?

The EUA enhances Lucira Health's product offerings and market potential, which can positively impact investor sentiment and stock performance.