Lucira’s lab quality PCR test has FDA OTC
(over the counter) clearance for all
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 for the first time ever, NBA fans can test
themselves for COVID-19 before attending a live game. This program
supports the Friday Chase Center reopening in San Francisco as the
Golden State Warriors host the Denver Nuggets.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210422005691/en/
For the first time ever, NBA fans can
test themselves for COVID-19 before attending a live game. The
testing program debuts in San Francisco Bay Area this Friday with
LUCIRA™ Check It COVID-19 At-Home Test. (Photo: Business Wire)
People buying tickets more
than seven days before tipoff are eligible for a free Lucira™ Check
It COVID-19 test kit. Within 11 minutes, the test tells users if
they have COVID-19. If they aren’t infected, they know within 30
minutes. Results are equivalent to the best PCR-quality lab tests,
but Lucira users perform the test themselves at home before coming
to the game.
California Department of Public Health guidelines require every
fan attending the game to have proof of a full vaccination, or a
negative COVID-19 test administered within 48 hours of the
game.
After self-testing with Lucira™ Check It test, they enroll in
CLEAR's Health Pass to securely link their test result and complete
a health survey to generate a Health Pass. That is shown for entry
to Chase Center.
“Lucira’s Check It test tested fans in Philadelphia on April
19th when the Warriors beat the 76ers,” said Lucira Health CEO Erik
Engelson. “Numerous COVID-19 studies have proven testing improves
safety and health, especially with large public gatherings. No
over-the-counter test has Lucira’s PCR quality accuracy in such an
easy to use form.”
Lucira™ Check It Test has OTC clearance from FDA On April
12, 2021, U.S. Food and Drug Administration (FDA) issued an
Emergency Use Authorization (EUA) for OTC sale of the Lucira™ Check
It COVID-19 test kit, delivering PCR quality molecular accuracy in
30 minutes or less at home. It is authorized and available for
individuals with or without symptoms and can be ordered from
lucirahealth.com for $55.
Lucira’s test was the first FDA authorized, prescription,
molecular diagnostic test for COVID-19 that could be
self-administered by patients at home or used in a physician’s
office. OTC clearance expanded availability of this highly accurate
test.
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 / supervised assistance.
To support people who would like to quickly receive confirmation
of their test results for work and other needs, Lucira partnered
with Converge Technology Solutions to develop a secure, text-based
way for people with smartphones to receive a free LUCI Pass™
without downloading an app. The LUCI Pass was developed to support
Lucira’s OTC test kit and is unique to Lucira. Users simply text a
short code to access LUCI, and then go through a simple sequence of
steps including scanning their test result to receive a LUCI Pass
and verified test to their phone. Results are also transmitted to
the relevant public health authorities.
Sensitive, accurate, easy to use In clinical trials,
Lucira’s easy-to-use ‘swab, stir and detect’ Check It test kit
demonstrated that 100% of users successfully performed the test in
about two minutes. Labs currently take 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 one of the
highest sensitivity molecular tests 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. 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/20210422005691/en/
Investor Contact Greg Chodaczek 347-620-7010
investorrelations@lucirahealth.com
Media Contact Kevin Knight 206-451-4823
media@lucirahealth.com
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