Jabil’s Michigan plant is joined by new
Dominican Republic facility
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 the
opening of a new production center in the Dominican Republic by its
manufacturing partner Jabil Inc. (NYSE: JBL). The new facility will
increase production of the LUCIRA CHECK IT™ COVID-19 test kit
during the second quarter of 2021. Jabil also manufactures Lucira’s
unique COVID-19 test in Auburn Hills, Michigan.
Lucira CEO Erik Engelson and senior executives from Jabil’s
Healthcare and Dominican Republic Operations attended the ribbon
cutting ceremony this Monday in the PIISA Industrial Park in Santa
Cristobal, Dominican Republic. They met afterwards with President
Luis Abinader and key government ministers.
“We started collaborating with Jabil before the pandemic after
evaluating a number of highly regarded manufacturers,” said
Engelson. “What impressed us most was the quality of their work,
experience in healthcare, and ability to scale quickly. We look
forward to working closely with their supply and production teams
so that our accurate, reliable COVID-19 test can help as many
people as possible.”
“We are thrilled to be working with Lucira Health at our
newly opened site in the Dominican Republic,” said David Panneton,
vice president, Diagnostics, Jabil Healthcare. “Our operation has
the ability to manufacture complex point-of-care / point-of-need
molecular diagnostic devices to detect COVID-19 and other
infectious diseases, all at large scale.”
The LUCIRA CHECK IT™ COVID-19 test kit is available over the
counter (OTC) in the United States. It is also the first self-test
authorized by Health Canada for individuals with or without
symptoms. Lucira’s identical prescription test kit is 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.
For users who need to share their test results, Lucira’s free,
text-based, easy-to-operate LUCI System can produce a LUCI PASS on
a smartphone. It is being used to show a negative test result at
entrances to conferences, arenas, and for travel and leisure.
Sensitive, accurate, easy to use
The LUCIRA CHECK IT™ COVID-19 test kit is designed to deliver
polymerase chain reaction (PCR) quality molecular accuracy in 30
minutes or less at home, and is available online at
lucirahealth.com for $55 U.S., excluding applicable taxes and
delivery charges.
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 telehealth or supervised assistance.
In clinical trials, Lucira’s easy-to-use ‘swab, stir and detect’
CHECK IT test kit demonstrated that 100 percent of users
successfully performed the test in less than two minutes. The
current centralized laboratory testing environment currently takes
two to fourteen days to generate similarly accurate test
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 sensitive and 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 percent, 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 percent of the time among
this sample, and negative results agreed 98 percent 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. For
guidance on care and public health reporting, people can use
Lucira’s text based, secure LUCI portal to receive a result
verification back on their phone while at the same time
transmitting their result 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, Lucira’s testing program for select
NBA fans. 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 filings 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/20210429005379/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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