Lucira Files for Authorization of First-of-its-Kind COVID-19 & Flu At-Home Molecular Test
May 12 2022 - 7:00AM
Lucira Health, Inc. ("Lucira Health" or "Lucira") (Nasdaq: LHDX), a
medical technology company focused on the development and
commercialization of innovative infectious disease tests, announced
today that it has submitted a request to the U.S. Food and Drug
Administration for emergency use authorization (EUA) for its
COVID-19 & Flu test. The request is for prescription at-home
use of the PCR-quality test for those with suspected COVID-19 or
Influenza. Lucira is seeking FDA authorization before this upcoming
fall and winter, when SARS-CoV-2 and influenza viruses are likely
to co-circulate.
"We are very proud to have reached this important milestone
toward introducing the first at-home COVID-19 & Flu test," said
Erik Engelson, President and CEO of Lucira Health. "Lucira was
founded to make lab-quality diagnostics more accessible to give
people who get sick a faster, cheaper, and easier path to
treatment. In this phase of the pandemic, with life-saving
antivirals available and less restrictions leading to the
reemergence of other respiratory viruses, we believe delivering a
highly accurate at-home test for both COVID-19 and flu can greatly
improve access to appropriate therapeutics in the window of time
when they are most effective."
The Lucira testing platform is a Nucleic Acid Amplification Test
(NAAT) with sensitivity and specificity comparable to lab-based PCR
assays, miniaturized to run on a palm-sized device with no separate
instrument, producing results within 30 minutes. Lucira's
standalone COVID-19 test was the first at-home COVID-19 test to
receive an EUA from the FDA in November 2020. The Lucira COVID-19
& Flu test uses the same platform and palm-sized device design
and independently tests for COVID-19, Flu A, and Flu B from a
single nasal swab.
Clinical trial results with the Lucira COVID-19 & Flu test
were positive, demonstrating comparable sensitivity and specificity
to leading lab-based PCR assays. The test recently received CE Mark
and submissions to other regulatory authorities are in
progress.
About the Lucira COVID-19 & Flu TestThe
Lucira COVID-19 & Flu test is a NAAT test utilizing the same
platform and device design as Lucira's commercialized EUA
authorized COVID-19 tests to provide independent diagnoses for
COVID-19, Flu A, and Flu B. The single-use test fits in the palm of
your hand, runs on 2 AA batteries, and with one nasal swab provides
a positive or negative result for COVID-19, Flu A, and Flu B in
less than 30 minutes. Each Lucira test contains everything needed
to run a single COVID-19 test: the test device, two AA batteries,
sample vial, swab, and simple instructions. There is no separate
reader or instrument to purchase and maintain. Lucira is seeking an
EUA for prescription at-home use of the test.
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 COVID-19 tests,
Lucira is working on new diagnostic tests including a single test
for COVID-19 & Flu, additional respiratory infections, and for
other categories including Sexually Transmitted Infections (STIs).
For more information, visit www.lucirahealth.com.
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," "seek,” "toward,"
"plans," "may," "anticipates," "expects," and similar expressions
are intended to identify forward-looking statements.
Forward-looking statements include statements regarding, among
others, the timing and availability, if approved, of Lucira's
COVID-19 & Flu test available throughout the United States.
These forward-looking statements 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, including Lucira's
ability to increase production, streamline operations and increase
product availability; the success of Lucira's test platform with
COVID-19 including its variants, Flu A and Flu B; the extent and
duration of the COVID-19 pandemic and Lucira's expectations
regarding customer and user demand for its COVID-19 test and the
COVID-19 and Flu test; Lucira's ability to obtain and maintain
regulatory approval for its tests, including Lucira's existing
Emergency Use Authorization for its COVID-19 test and LUCI Pass;
Lucira's expectations around the timing of submission and receipt
of regulatory approval for its tests; the performance of, and
Lucira's reliance on, third parties in connection with the
commercialization of its tests, including Jabil Inc., Switch Health
and Lucira's single-source suppliers; Lucira's ability to
successfully continue to expand internationally; any impact on
Lucira's ability to market its tests; demand for Lucira's tests due
to deferral of procedures using its tests or disruption in its
supply chain; Lucira's ability to achieve or sustain profitability;
Lucira's ability to gain market acceptance for its tests and to
accurately forecast and meet customer demand; Lucira's ability to
compete successfully; Lucira's ability to enhance and expand its
product offerings; Lucira's ability to accurately predict continued
expansion; Lucira's ability to accurately forecast revenue;
development and manufacturing problems; capacity constraints or
delays in production of Lucira's tests; maintenance of coverage and
adequate reimbursement for procedures using Lucira's tests; and
test defects or failures. These and other risks and uncertainties
are described more fully in the "Risk Factors" section and
elsewhere in Lucira's filings with the Securities and Exchange
Commission and available at www.sec.gov, including in its most
recent Annual Report on Form 10-K and subsequently filed reports.
Any forward-looking statements that Lucira makes in this
announcement speak only as of the date of this press release, and
Lucira assumes 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 ContactMike
StommelLucira@luckybreakpr.com323-333-2901
Investor ContactGreg
ChodaczekInvestorrelations@lucirahealth.com332-895-3230
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