LUCIRA™ CHECK IT PCR Quality, at Home Molecular COVID-19 Test Kit Now Available on Amazon
November 09 2021 - 7:00AM
Lucira Health, Inc. ("Lucira Health" or "Lucira") (Nasdaq: LHDX), a
medical technology company focusing on the development and
commercialization of transformative and innovative infectious
disease test kits, announced that its LUCIRA™ CHECK IT COVID-19
Test Kit, a self-administered PCR quality, single-use, at home
molecular diagnostic test for COVID-19, is available for purchase
by Amazon U.S.-customers.
"We are delighted that our LUCIRA™ CHECK IT COVID-19 test kit is
once again available to Amazon U.S.-customers," said Erik Engelson,
Chief Executive Officer. "Access to a COVID-19 test with the
PCR-level accuracy and early detectability that you get from a lab
test combined with the speed and simplicity of our test kit can
help Americans confidently return to work or school and to get back
to gathering live with family and friends this upcoming holiday
season. Amazon's reach enables more people in the United States
access to this innovative and unique testing solution.
The test kit, authorized for emergency use by FDA under EUA, is
available over the counter ("OTC"), and can produce a positive
result in as little as 11 minutes, or a negative result within 30
minutes. Immediately after testing, users can access a free, text
based digital LUCI PASS™ verified test result on their
phone for work, travel, and leisure.
Accurate, easy to use
The LUCIRA™ CHECK IT COVID-19 test kit is designed to deliver
PCR quality molecular accuracy in 30 minutes or less at home. Each
single-use test kit contains everything needed to conduct one
COVID-19 test. 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 such as a reader or instrument to purchase.
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.
Molecular tests are more sensitive than antigen tests because
they amplify critical parts of the viral target. The targeted,
molecular amplification that LUCIRA™ CHECK IT and PCR tests employ
makes them demonstrably more reliable than "rapid" antigen tests,
which can miss active COVID-19 infections.
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%, detecting 385 out of 394
positive and negative samples correctly when compared to the
Hologic Panther Fusion, and 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.
LUCIRA™ CHECK IT Test Kit
The LUCIRA™ CHECK IT test
kit fits in the palm of a hand, extracts
genetic material from the virus and amplifies it similar to PCR lab
tests. 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 one-page 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
in each nostril five times. 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. Lucira also offers a
free LUCI PASSTM digital verified test result back to a
user's phone. LUCI 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.
Lucira's identical, prescription product is also available for
sale to healthcare providers
at lucirahealth.com
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, the impact to our
business of the ongoing COVID-19 pandemic; 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 Reports 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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