Lucira™ Check-It PCR-Quality, At-Home Molecular COVID-19 Test Now Available in the Optum Store
January 11 2022 - 7:00AM
Lucira Health, Inc. ("Lucira Health" or "Lucira") (Nasdaq: LHDX), a
medical technology company focused on the development and
commercialization of transformative and innovative infectious
disease test kits, announced that its Lucira™ Check-It
PCR-Quality, At-Home Molecular COVID-19 Test is now available in
the Optum Store (store.optum.com).
"Expanding access to Lucira's first-of-its-kind test is critical
in the face of the current surge of COVID-19 cases. Our at-home
molecular test delivers the lab-quality accuracy of PCR combined
with the rapid, on-the-spot results of antigen tests, so you can
detect early COVID-19 infection, including Omicron, before
potentially putting others at risk," said Erik Engelson, President
and Chief Executive Officer of Lucira Health. "The Optum Store
connects consumers with high-quality, affordable health products
and services to improve their overall health and care, and we're
proud to offer our tests to their customers."
The Lucira Check-It COVID-19 test kit has emergency
authorization by FDA under EUA.
Lucira™ Test Kits
The Lucira™ Check-It (OTC) and All-In-One (Rx) test kits are
molecular 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. 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 and expand our product offerings; our ability to
accurately predict continued expansion; our ability to accurately
forecast revenue; 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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