Lucira Health, Inc. ("Lucira") (Nasdaq: LHDX), a medical technology
company focused on the development and commercialization of
transformative and innovative infectious disease test kits,
announced a new distribution agreement for at least 600,000 tests
in 2022 with Co-Defend, Inc. and Co-Protect, LLC, leading providers
of customized health, safety, and wellness solutions.
"We want to make our first-of-its-kind test as widely available
as possible so people don't have to choose between rapid antigen
tests that can't reliably detect infection before symptoms and
lab-based PCR tests that are difficult to access and take days to
deliver results," said Erik Engelson, President and Chief Executive
Officer of Lucira Health. "Co-Defend and Co-Protect provides
solutions to the biggest names in sports, entertainment and
enterprise scaled businesses. Their extensive reach and L.A.-based
distribution platform plus Lucira's innovative on-the-spot
molecular test means more Americans will have access to the peace
of mind of a reliable, real-time test result before attending an
event, returning to work, or gathering with family and
friends."
Adrian Cottman, President and Co-Founder of Co-Defend, and
COO/EVP of Co-Protect, stated, "Rapid, point-of-care testing is a
critical tool for infection prevention and should be included in
every organization's health and safety protocols to prevent the
spread of the virus. Our companies minimize business disruption and
get people back to living in this 'new normal'. Lucira's superior
testing technology combined with our broad distribution channels
will make an immediate positive impact on public health."
Lucira Check-It COVID-19 test kit has emergency authorization by
FDA under EUA.
LUCIRA™ Test Kits
The Lucira™ Check-It (OTC) and All-in-One (Rx) test kits are
Nucleic-Acid Amplification Tests (referred to as NAAT). The tests
fit in the palm of your hand, extract genetic material from the
virus and amplify it, similar to PCR lab tests, to detect the
presence of virus earlier and more accurately than antigen tests.
The test uses an approach called reverse transcriptase
loop-mediated isothermal amplification (RT-LAMP). It was designed
and tested extensively for individuals to use independently and
does not require a physician's prescription or supervised
assistance. There is no additional equipment to purchase, such as a
reader or instrument.
Each Lucira test kit contains everything needed to run one
COVID-19 test. Users get the test device, two AA batteries, sample
vial, swab, and simple instructions. The batteries are inserted
into the device and the sample vial is placed in the test unit. The
user then opens the test swab packet and rotates the swab five
times in each nostril. The swab is then stirred in the sample vial,
which is then gently pressed into the test unit to start the test.
The "ready" light will blink until a "positive" or "negative" green
light is illuminated within 30 minutes. In the US, Lucira also
offers a free LUCI Pass™ digital verified test result back to a
user's phone. LUCI Pass is accessed via text and does not require
downloading an app. There is also an opt-in for public health
reporting for users who wish to transmit their results to the
relevant public health authorities.
In clinical trials, 100% of users successfully performed the
test at home in about two minutes using Lucira's easy-to-use 'swab,
stir and detect' Check-It test kit.
In a Community Trial setting, Lucira™ Check-It results were
compared with the Hologic Panther Fusion, considered a
high-sensitivity molecular test due to its low Limit of Detection
("LOD"). Lucira's accuracy was 98%, correctly detecting 385 out of
394 positive and negative samples in comparison to the Hologic
Panther Fusion, excluding ten samples with very low levels of virus
(those with very high PCR cycle thresholds of 37.5 or greater) that
possibly no longer represented active infection. Comparative
positive results agreed 97% of the time among this sample, and
negative results agreed 98% of the time.
Last month, Lucira announced confirmation that its COVID-19
Check-It molecular self-test kits can detect 100% of Omicron
variant genome sequences analyzed, including the "stealth variant".
Lucira assays target viral sequence regions unaffected by the spike
protein mutations found in Omicron, Delta and other Variants of
Concern, allowing it to maintain its accuracy in the face of an
evolving virus.
About Lucira Health
Lucira is a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits. Lucira's testing platform produces
lab quality molecular testing in a single-use, consumer-friendly,
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. The Lucira™ Check-It
COVID-19 Test Kit (OTC) and Lucira™ COVID-19 All-In-One Test Kit
(Rx) are designed to provide a clinically relevant COVID-19 result
within 30 minutes from sample collection. For more information,
visit www.lucirahealth.com.
About Co-Defend and Co-Protect
Co-Defend and Co-Protect began in 2019, providing solutions for
large scale sports events and arenas who were seeking to re-start
operations during COVID-19. The Los Angeles based companies
specialize in customized COVID solutions for companies, governments
and sports leagues; their license portfolio features NBA, MLB, MLS
and several prominent Universities. As the most innovative company
in protective wellness, Co-Defend and Co-Protect solutions offer an
array of COVID testing, branded personal protective equipment, and
a sophisticated vaccine verification and health data management
platform used by millions of consumers.
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," "plans," "will," "may," "anticipates," "expects,"
"potential," and similar expressions are intended to identify
forward-looking statements. 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 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
test kit; our ability to obtain and maintain regulatory approval
for our test kits, including our existing Emergency Use
Authorization for our COVID-19 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 successfully continue to
expand internationally; any impact on our ability to market our
products; demand for our products due to deferral of procedures
using our products or disruption in our supply chain; our ability
to achieve or sustain profitability; our ability to gain market
acceptance for our products and to accurately forecast and meet
customer demand; our ability to compete successfully; our ability
to enhance our product offerings; development and manufacturing
problems; capacity constraints or delays in production of our
products; maintenance of coverage and adequate reimbursement for
procedures using our products; and product defects or failures.
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.
Investor ContactGreg
ChodaczekInvestorrelations@lucirahealth.com347-620-7010
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