LUCIRA COVID-19 Test Kit Identifies Viral Variants
09 April 2021 - 8:00PM
Business Wire
LUCIRA COVID-19 All-In-One Test Kit reactive to
at least 99.9% of all known COVID-19 virus strains
Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company
focused on the development and commercialization of transformative
and innovative infectious disease test kits, today confirmed it can
successfully identify the “double mutant” variant of COVID-19 with
its Lucira molecular test kit.
The “double mutant” variant was first identified in India on
March 24, 2021, and found in California on March 25, 2021, by
Stanford Clinical Virology Lab scientists. Unlike other variants,
it has two genetic mutation sequences that the Center for Disease
Control (CDC) is tracking.
According to Lucira Health Chief Technology Officer and
co-founder Debkishore Mitra, Ph.D., variants occur when viruses
replicate themselves. These variants include well-known strains
first discovered in England, South Africa, and Brazil. Variants can
occur when the genetic code packaged inside the virus starts
copying itself and the new copies inadvertently start replicating a
new, mutant code. These errors can cause a virus to elude the
immune system and become more challenging to detect.
“A test is only helpful if it can detect the virus it’s designed
to find,” said Dr. Mitra. “That’s why we started routinely
monitoring COVID-19 viral variants, even before the FDA’s voluntary
guidelines were released this February. As sequences from new virus
strains become available, we compare their genetic code with our
test using a well-established, extremely accurate computer
model.
“Since we began this monitoring, our Lucira test kit has been
reactive to more than 99.9% of available COVID-19 viral sequences,
which are roughly 30,000 letters long. It’s complex work, but
really important since users rely on our test for accurate
results.”
Dr. Mitra added, “Our focus is on providing a test that’s easy
for an individual to use and extremely accurate. If someone uses
our ‘gentle swab’ test and has COVID-19, they can know in as few as
11 minutes on-the-spot. If they are not infected, they will know
within 30 minutes. Precision and performance matter, and we can’t
afford to let any variants escape detection.”
Lucira Health’s U.S. designed and manufactured product was the
first FDA-authorized, prescription, molecular diagnostic test for
COVID-19 that could be fully self-administered by patients at home
or used in a physician’s office. Results are produced
on-the-spot.
Each single-use LUCIRA COVID-19 All-In-One Test Kit can conduct
one COVID-19 test and be ordered by healthcare professionals from
lucirahealth.com.
Sensitive, accurate, easy to use
Lucira’s easy-to-use ‘swab, stir and detect’ test platform
demonstrated that 100% of users successfully performed the test in
less than about two minutes of hands-on time in usability testing.
The current centralized laboratory testing environment takes two to
14 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 COVID-19 All-In-One Test Kit
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-based clinical trial, the LUCIRA COVID-19
All-In-One Test Kit 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 achieved a 94%
positive percent agreement (PPA) and a 98% negative percent
agreement (NPA). Excluding samples with very low levels of virus
that possibly no longer reflected active infection, Lucira achieved
100% positive percent agreement. Lucira has since completed an
additional Community Testing study among asymptomatic individuals
and this data is currently under FDA review.
LUCIRA ALL-IN-ONE Test Kit
The LUCIRA COVID-19 All-In-One Test Kit 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 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.
About Lucira Health
Lucira Health 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 COVID-19
All-In-One Test Kit (RX) are designed to provide a clinically
relevant COVID-19 result within 30 minutes from sample
collection.
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Investor Contact Greg Chodaczek 347-620-7010
investorrelations@lucirahealth.com
Media Contact Kevin Knight 206-451-4823
media@lucirahealth.com
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