Lucira Announces Health Canada Authorization of First and Only 99% Accurate At-Home Covid & Flu Test
August 11 2022 - 7:01AM
Lucira Health, Inc. (Nasdaq: LHDX) ("Lucira Health," "Lucira" or
the "Company"), a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease tests, today announced that Health Canada has
granted Authorization under Interim Order for the emergency use and
commercialization of the first and only at-home test for COVID
& Flu. The Lucira COVID-19 & Flu Test is a 99% accurate
rapid molecular test that delivers results in 30 minutes or less
from one shallow nasal swab.
Distribution of the COVID-19 & Flu Test in Canada will be
prioritized along with the current COVID-19 Test and is available
to institutions, agencies, and consumers in advance of the
approaching fall and winter COVID and Flu season. Lucira’s COVID-19
& Flu Test is available now for online ordering at:
www.lucirahealth.ca.
“When influenza and Covid-19 co-circulate this winter, millions
who don’t feel well will be asking ‘is it Covid-19 or flu?’ so they
can take the appropriate action to get better. Only the Lucira
COVID-19 & Flu Test, a single at-home test with 99% accuracy,
can answer this question immediately,” said Erik Engelson,
President and Chief Executive Officer of Lucira Health. “We
appreciate Health Canada for its careful and thorough assessment of
the Lucira COVID-19 & Flu Test. This timely action is expected
to help Canadians accurately test at-home in advance of flu season,
keep more people out of the emergency departments, and provide a
rapid treatment pathway.”
Health Canada’s decision is based on performance data reviewed
under Health Canada’s expedited authorization pathway, Interim
Order No. 3. As a part of the authorization process, clinical
data gathered from both retrospective remnant samples and
prospective clinical studies were included in support of the Lucira
COVID-19 & Flu Test performance against recognized PCR Lab
based tests. A combined total of 677 samples were tested
across both studies, of which 425 samples were included in the
Retrospective Remnant Study and an additional 252 subjects enrolled
in the Prospective Study.
About Lucira COVID-19 & Flu Test
The Lucira COVID-19 & Flu Test is a NAAT test utilizing the
same platform and device design as Lucira’s COVID-19 Test 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 two AA
batteries, and with one nasal swab, provides a positive or negative
result for COVID-19, Flu A, and Flu B in 30 minutes or less. Each
Lucira test is packaged with everything needed to run a single
test: the test device, two AA batteries, sample vial, swab, and
simple instructions. 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 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 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," “expect,” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements, including but not limited to, statements regarding the
distribution of the COVID-19 & Flu Tests in Canada, the
upcoming winter respiratory disease season in Canada, accuracy of
our COVID-19 & Flu Test, the demand of our COVID-19 & Flu
Test by Canadian consumers, ; 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 our ability to
increase production, streamline operations and increase product
availability; the success of our test platform with COVID-19
including its variants, the extent and duration of the COVID-19
pandemic and our expectations regarding customer and user demand
for our COVID-19 and influenza test kits; our expected future
growth; our ability to obtain and maintain regulatory approval for
our test kits, including our existing Emergency Use Authorization
for our COVID-19 and influenza test kits and LUCI Pass; the size
and growth potential of the markets for our test kits, including
the COVID-19 and influenza diagnostic testing market, and our
ability to serve those markets; our ability to accurately forecast
demand for our test kits; the rate and degree of physician and
market acceptance of our test kits; the expected future growth of
our sales and marketing organization; coverage and reimbursement
for our test kits; the performance of, and our reliance on, third
parties in connection with the commercialization of our test kits,
including Jabil Inc. and our single-source suppliers; our ability
to accurately forecast, and Jabil’s ability to manufacture,
appropriate quantities of our COVID-19 and influenza test kits to
meet commercial demand; regulatory developments in the United
States and foreign countries; our research and development for any
future test kits; the development, regulatory approval, and
commercialization of competing products; our ability to retain and
hire senior management and key personnel; our ability to develop
and maintain our corporate infrastructure, including our internal
controls; our financial performance and capital requirements; our
expectations regarding our ability to obtain and maintain
intellectual property protection for our test kits, as well as our
ability to operate our business without infringing the intellectual
property rights of others; and our ability to navigate unfavorable
global economic conditions that may result from recent geopolitical
events, including the COVID-19 pandemic, Russia’s military
intervention in Ukraine, and the global sanctions imposed by
countries against Russia that followed. These and other 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 Quarterly Report on Form
10-Q. Any forward-looking statements that we make 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 Relations
Holly Windlermedia@lucirahealth.com 619-929-1275
Investor Relations Greg
Chodaczekinvestorrelations@lucirahealth.com 347-620-7010
Photos accompanying this announcement are available
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