Lucira Health Announces FDA Authorization of Combination COVID-19 & Flu Test at Point-of-Care
22 Novembre 2022 - 10:02PM
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 TestThe
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 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, 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 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,”
“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
StommelLucira@luckybreakpr.com323-333-2901
Investor ContactGreg
ChodaczekInvestorrelations@lucirahealth.com332-895-3230
Photos accompanying this announcement are available
at:
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