Lucira Health Announces Expanded Partnership with Switch Health to Increase Canadians' Access to At-Home Molecular COVID-19 Tests
December 22 2021 - 7:00AM
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 agreement with Switch Health Solutions Inc.
("Switch Health") to increase Canadians' access to at-home
molecular COVID-19 tests as Omicron cases surge. Lucira will
provide more than 2 million at-home COVID-19 test kits in 2022 as
part of the deal.
"As Omicron cases surge around the world, the need for better
testing solutions has never been more apparent," said Erik
Engelson, President and Chief Executive Officer of Lucira. "Only
Lucira's tests provide a PCR-quality test result in 30 minutes,
wherever you are, from a simple, single-use kit. Making these tests
more available is critical to help slow the spread of
COVID-19."
Switch Health is a Canadian healthcare company dedicated to
providing better decentralized patient care. Switch Health has
quickly become a leader in COVID-19 testing on-site at its Switch
Health Clinics and at-home through its remote telehealth service
and in-person visits.
"Switch Health's ability to be a Canadian health care leader in
decentralized diagnostics is in large part due to the innovative
technologies we make available to everyday Canadians," added Marc
Thomson, Chief Operating Officer at Switch Health. "Lucira has been
an instrumental partner in helping Switch Health achieve that in
the COVID-19 era. Together, we are removing barriers to get
Canadians safely back to work and reunited with their loved
ones."
Last month, Lucira announced confirmation that its COVID-19
Check-It (OTC) and All-In-One (Rx) 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.
Lucira has received Interim Order authorization from Health
Canada to sell and distribute its COVID-19 test kits for at-home
self-testing in Canada.
LUCIRA™ CHECK IT Test Kit
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.
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.
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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