Lucira Health Announces U.S. Launch of First & Only At-Home Combination COVID-19 & Flu Test Amidst Sale Process
March 28 2023 - 8:05AM
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
TestThe 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 HealthLucira 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 StatementsStatements 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
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