LUCIRA™ CHECK IT COVID-19 Self-Test Now Available on Amazon
May 12 2021 - 6:00AM
Business Wire
This FDA EUA first and only PCR quality,
single-use, COVID-19 at home, self-test kit is available for $55 to
all Amazon US customers
Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company
focused on the development and commercialization of transformative
and innovative infectious disease test kits, today announced that
its LUCIRA™ CHECK IT COVID-19 test kit is now available on
Amazon.com in the US. Each LUCIRA CHECK IT test kit provides a PCR
quality test result at home in 30 minutes or less. After testing,
users can also receive a free, text based digital LUCI PASS
verified test result on their phone for work or travel. The product
costs $55 and includes free standard shipping.
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LUCIRA™ CHECK IT COVID-19 self-test is
now available on Amazon. Each test kit provides a PCR quality test
result at home in 30 minutes or less. (Photo: Business Wire)
Lucira CEO Erik Engelson said, “We are excited to offer the
first at-home COVID-19 self-test to provide an on-the-spot result
with molecular accuracy available to millions of US customers on
Amazon. We are looking forward to making our test available to more
customers thanks to its availability on Amazon.”
Lucira Executive Vice President Kelly Brezoczky added, “We’re
proud Amazon has made Lucira’s PCR quality over-the-counter COVID
test available in its store. We’re making it easy for people to
test at home, and then go places with our LUCI PASSTM test result
on their phone.”
Lucira developed the LUCI PASSTM to provide users an easy way to
receive a digital verified test result. Customers simply text the
word “LUCI” to 44544 and then follow the simple steps to upload
their test results. All test results are digitally verified through
LUCI’s secure portal. Once users have a LUCI PASS on their phone
they can show their negative test result at entrances to
conferences, workplaces, arenas, and for travel and leisure.
The LUCIRA™ CHECK IT COVID-19 test kit is available over the
counter (OTC) in the US. LUCIRA’s prescription version was the
first U.S. FDA EUA-authorized, prescription, molecular diagnostic
test for COVID-19 that can be self-administered by patients at home
or used in a physician’s office. It is also the first self-test
authorized by Health Canada for individuals with or without
symptoms.
Sensitive, 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.
In clinical trials, 100% of users successfully performed
self-testing at home in less than two minutes using Lucira’s
easy-to-use ‘swab, stir and detect’ CHECK IT test kit. The current
centralized laboratory testing environment currently takes two to
fourteen days to generate similarly accurate results.
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 instructions. The batteries
are inserted in 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 user who wish to transmit their results to the
relevant public health authorities.
Lucira still has its identical, prescription product available
for sale to healthcare providers at lucirahealth.com
About Lucira Health, Inc.
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 (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.
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. Such forward-looking statements include statements
regarding, among other things, the continued availability of
Lucira’s test kit on Amazon. 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, which include, without limitation,
risks and uncertainties associated with Lucira’s business in
general and the other risks described in Lucira’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
March 31, 2021 and subsequent filings made by Lucira with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date. Lucira undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made,
except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210512005367/en/
Lucira Health Media Contact Kevin Knight 206-451-4823
media@lucirahealth.com
Lucira Health Investor Contact Greg Chodaczek 347-620-7010
investorrelations@lucirahealth.com
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