Lucira Receives CE Mark for both COVID-19 & Flu and COVID-19 Molecular Tests
May 09 2022 - 8:00AM
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
that both its COVID-19 & Flu and COVID-19 molecular tests have
received CE Mark for professional use, clearing both tests for sale
and distribution throughout the European Union.
The Lucira COVID-19 & Flu and COVID-19 tests are Nucleic
Acid Amplification Tests (NAAT) with sensitivity and specificity
comparable to lab-based PCR assays, miniaturized to run on a
palm-sized device with no separate instrument or reader, producing
results in 30 minutes. Lucira's COVID-19 test is currently
available in the US, Canada, Singapore, Israel, and Taiwan with
millions of tests distributed to date. 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 with results in less than 30 minutes.
"The Lucira testing platform can make highly accurate molecular
point-of-care testing more accessible than previously possible with
our simple test that requires no separate instrument or reader,
internet connection, or power cord," said Erik Engelson, the
President and CEO of Lucira Health. "Receiving CE Mark for both our
COVID-19 & Flu and COVID-19 tests represents a major milestone
for Lucira to expand our product-line and our geographic
reach."
COVID-19 and flu have similar symptoms but distinct treatments,
making tests to differentiate between these infections crucial when
the viruses that cause them are both in circulation. Lucira plans
to make its COVID-19 & Flu test available in the European Union
beginning in the third quarter of 2022 in advance of the Northern
Hemisphere influenza season.
Clinical trial results with the Lucira COVID-19 & Flu test
were positive and submissions to other regulatory authorities,
including the U.S. Food & Drug Administration and Health
Canada, are planned for the second quarter of 2022 with decisions
expected before this upcoming flu season.
About the Lucira COVID-19 TestThe Lucira
COVID-19 test is a Nucleic-Acid Amplification Test (NAAT). The test
fits in the palm of your hand, extracts genetic material from the
virus and amplifies it, similar to PCR lab tests, to detect the
presence of virus earlier and more accurately than antigen tests.
There is no additional equipment to purchase, such as a reader or
instrument. 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.
About the Lucira COVID-19 & Flu TestThe
Lucira COVID-19 & Flu test is a molecular test utilizing the
same platform and device design as Lucira's 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.
About Lucira HealthLucira is a medical
technology company focused on the development and commercialization
of transformative and innovative infectious disease tests. Lucira's
testing platform produces lab quality molecular testing in a
single-use, easy-to-use, palm-size test kit powered by two AA
batteries. Lucira designed its test kits to provide accurate,
reliable, and on-the-spot molecular test results anywhere and at
any time.
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," "plans," "may,"
"anticipates," "expects," and similar expressions are intended to
identify forward-looking statements. Forward-looking statements
include statements regarding, among others, Lucira's planned
regulatory submissions of its COVID-19 and Flu test to other
regulatory authorities and the timing and availability of Lucira's
COVID-19 & Flu test available throughout the European Union.
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
Photos accompanying this announcement are available at:
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