EMERYVILLE, Calif.,
Feb. 3, 2022 /PRNewswire/ -- 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 more than two million
Lucira™ Check-It COVID-19 tests, a rapid
at-home test with PCR-quality accuracy, are available on
Amazon.com. Lucira's tests are available with 1-2 day Prime
delivery nationwide.
Lucira Health announces more than two million of its molecular
COVID-19 at-home tests are available on Amazon.com
Nationwide surges of COVID-19 cases have resulted in overwhelmed
testing sites and processing labs, making accurate at-home test
options more critical than ever. Lucira's innovative tests uniquely
combine the speed and at-home usability of rapid antigen tests and
the accuracy and early detection of PCR. Lucira's tests are
amplification tests, meaning they amplify virus genetic material,
just like PCR tests, but are miniaturized to fit in the palm of
your hand and were shown to be 98% accurate in a head-to-head
comparison to one of the most sensitive lab-based PCR tests.
Results are available in 30 minutes and the test works in three
easy steps with no prescription required. At $75, the Check-It COVID-19 test kit is priced
less than most lab-based PCR tests and mail-in PCR kits, both of
which can take up to 2-4 days to receive results. Lucira Check-It
tests are also eligible for the recently announced at-home test
reimbursement from private insurers.
"We have worked tirelessly to ensure Lucira Check-It COVID-19
tests are more accessible to the public," said Erik Engelson, Lucira Health's Chief Executive
Officer. "Access to a COVID-19 test with PCR-level accuracy and
early detectability, previously only available from a lab test, in
30 minutes without leaving your home can help Americans confidently
return to work or school and get back to gathering in-person with
family and friends. Amazon's distribution network enables more
people in the United States to
access this innovative and unique testing solution."
The test kit, the first and only single-use at-home
amplification test authorized for emergency use by FDA, 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.
The Check-It COVID-19 test kit costs $75 for a single test. The list price is
$89 with a $14 coupon available on amazon.com. Tests are
also available on www.lucirahealth.com.
The Lucira Check-It COVID-19 test kit has emergency
authorization by FDA under EUA.
LUCIRA™ Check-It Test Kit
The Lucira™ Check-It (OTC) test is a Nucleic-Acid Amplification
Tests (referred to as NAAT). The test fits in the palm of your
hand, extracts genetic material from the virus and amplifies 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.
In a community trial setting, Lucira™ Check-It results were
compared with the Hologic Panther Fusion, which is 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
likely 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 has announced confirmation that its COVID-19 Check-It
molecular self-test kits can detect 100% of Omicron variant genome
sequences analyzed, including sub-variant BA.2, as of January 11, 2022. 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.
Each Lucira test kit contains everything needed to run a single
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.
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 Lucira's ability to increase production,
streamline operations and increase product availability; the
success of Lucira's test platform with COVID-19 including its
variants; the extent and duration of the COVID-19 pandemic and
Lucira's expectations regarding customer and user demand for its
COVID-19 test kit; Lucira's ability to obtain and maintain
regulatory approval for its test kits, including Lucira's existing
Emergency Use Authorization for its COVID-19 test kits; the
performance of, and Lucira's reliance on, third parties in
connection with the commercialization of its test kits, including
Jabil Inc. and Lucira's single-source suppliers; Lucira's ability
to successfully continue to expand internationally; any impact on
Lucira's ability to market its products; demand for Lucira's
products due to deferral of procedures using its products or
disruption in its supply chain; Lucira's ability to achieve or
sustain profitability; Lucira's ability to gain market acceptance
for its products and to accurately forecast and meet customer
demand; Lucira's ability to compete successfully; Lucira's ability
to enhance and expand its product offerings; Lucira's ability to
accurately predict continued expansion; Lucira's ability to
accurately forecast revenue; development and manufacturing
problems; capacity constraints or delays in production of Lucira's
products; maintenance of coverage and adequate reimbursement for
procedures using Lucira's products; and product defects or
failures. These and other risks and uncertainties are described
more fully in the "Risk Factors" section and elsewhere in Lucira's
filings with the Securities and Exchange Commission and available
at www.sec.gov, including in its 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.
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SOURCE Lucira Health