U.S. Physicians Can Now Order Lucira Health Self-Administered, Lab Quality, COVID-19 Molecular Test for Home or Office
February 11 2021 - 6:00AM
Business Wire
--- Lab-quality results in 30 minutes or
less ---
Lucira Health, Inc. (Nasdaq: LHDX), today announced that U.S.
physicians and healthcare providers can now order Lucira COVID-19
All-In-One Test Kits online from lucirahealth.com. This U.S. made
and manufactured product is the first FDA authorized, prescription,
molecular diagnostic test for COVID-19 that can be
self-administered in a physician’s office, or used by patients at
home. Each single-use test kit costs $50 and contains everything
needed to conduct one COVID-19 test. It can produce a positive
result within 11 minutes, or a negative result within 30
minutes.
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Lucira COVID-19 All-In-One Test Kits can
be self-administered in a physician’s office, or used by patients
at home. (Photo: Business Wire)
“Physicians in private practice like myself have been
overwhelmed by patients suspected of having COVID-19. All of us
want fast, accurate test results in minutes, not days. The Lucira
test makes that possible,” said Dr. Neeraj Kochhar, M.D., a family
medicine specialist in Los Gatos, California.
U.S. physicians who order the test can use it in their offices,
or provide it to patients suspected of having COVID-19. It is the
first molecular test kit that can be self-administered, and was
designed and tested for use at home without requiring any
telehealth or supervised assistance.
Featuring an easy-to-use ‘swab, stir and detect’ design,
clinical trials showed 100% of patients were successfully able to
perform the Lucira test in about two minutes. Labs currently take
two to fourteen days to generate similarly accurate test
results.
High sensitivity molecular tests like Lucira’s are significantly
more sensitive than “rapid” antigen tests which do not work as well
at very low viral loads. The result is they can miss active
COVID-19 infections. Molecular tests such as PCR (polymerase chain
reaction) and Lucira’s test are considered diagnostically
definitive, unlike antigen tests which can require confirmatory
molecular testing.
In a Community Trial setting, Lucira test results were compared
with the Hologic Panther Fusion, which is considered one of the
current market-leading molecular assays in an FDA published study
because of its low Limit of Detection. The comparative positive
results agreed 94% of the time across all samples, and 100% of the
time excluding samples containing very low levels of virus (at or
below 37.5 Ct). The negative results agreed 98% of the time across
all samples.
Portable, accurate test
Lucira’s COVID-19 All-In-One 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. Next,
the user opens the test swab packet and rotates the swab in each
nostril five times. The swab is then stirred in the sample vial,
and then pressed down in 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, patients will contact or report their test
results to the healthcare provider that prescribed the test.
Lucira Health
Lucira Health a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits. Lucira has developed a testing
platform that produces centralized-laboratory-accurate molecular
testing in a single-use and consumer-friendly test kit that is
powered by two AA batteries and fits in the palm of a hand. 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 is designed to provide a
clinically relevant COVID-19 result within 30 minutes from sample
collection.
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Kevin Knight, Tel: 206-451-4823
Lucira Health (NASDAQ:LHDX)
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