LUCIRA™ CHECK IT COVID-19 Test Kit is Available for Online Purchase
October 26 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 again available for
online purchase.
“We are excited that during the ongoing uncertainty we can again
support the need for an easy to use, at home, accurate testing
option that produces PCR quality results on-the-spot,” said Erik
Engelson, Chief Executive Officer. “We continue to see an increased
need for our LUCIRA™ CHECK IT COVID-19 test kit and reopening our
online sales channel via our website allows for greater access to
our product.”
Each single-use test kit costs $75. 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. After testing,
users can also access a free, text based digital LUCI
PASS™ verified test result on their phone for work or
travel.
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 PASS™ 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. Such forward-looking statements include statements
regarding, among other things, Lucira's continued development and
commercialization of its transformative and innovative infectious
disease test kits and ability to increase sales. 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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