Health Canada Authorizes First COVID-19 Test For Self-Testing At Home
April 26 2021 - 9:35AM
Business Wire
LUCIRA™ CHECK IT COVID-19 Self-Test Receives
Interim Order Authorization
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
Health Canada issued an Authorization with Conditions for the
LUCIRA™ CHECK IT COVID-19 test kit. The Authorization with
Conditions was issued by Health Canada under the Interim Order (IO)
Respecting the Importation and Sale of Medical Devices for Use in
Relation to COVID-19.
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Health Canada issues Authorization with
Conditions for LUCIRA™ CHECK IT COVID-19 Self-Test. It is the first
self-test authorized by Health Canada for individuals with or
without COVID-19 symptoms. (Photo: Business Wire)
The LUCIRA™ CHECK IT COVID-19 test kit is the first self-test
authorized by Health Canada for individuals with or without
symptoms. It delivers PCR quality molecular accuracy in 30 minutes
or less at home and is expected to be available online for
Canadians to order by June 2021 for approximately $75.00 CAD,
excluding applicable taxes and delivery charges.
Lucira CEO Erik Engelson commented, “Canada has a global
reputation for world-class health care. We are proud our self-test
was the first one authorized for use within this vast country.
Numerous COVID-19 studies have demonstrated that testing improves
safety and health, and no other self-test has Lucira’s PCR quality
accuracy in such an easy to use form.”
Each LUCIRA™ CHECK IT COVID-19 test kit is a single-use test kit
containing everything needed to conduct one COVID-19 test. It can
detect a positive result in as few as 11 minutes or confirm a
negative result within 30 minutes. It was designed and tested
extensively for individuals to use independently and does not
require a physician’s prescription or telehealth / supervised
assistance.
As with Canada, the LUCIRA™ CHECK IT COVID-19 test kit is the
first and only U.S. FDA Emergency Use Authorization (EUA)
over-the-counter, single-use, PCR quality molecular test for
COVID-19 that can be self-administered at home. Lucira’s test kit
is also authorized in the U.S. for prescription at-home and point
of care use.
Sensitive, accurate, easy to use
In clinical trials, the LUCIRA™ CHECK IT COVID-19 test kit’s
easy-to-use ‘swab, stir and detect’ sequence demonstrated that 100%
of users successfully performed the test in less than two minutes.
Current centralized laboratory tests can typically take 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™ CHECK IT COVID-19 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 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.
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 test
kit is designed to provide a clinically relevant COVID-19 result
within 30 minutes from sample collection. In the US, Lucira also
offers the LUCIRA™ COVID-19 All-In-One test kit for point of care
and prescription at home use.
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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 31, 2021. 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/20210426005544/en/
Media Contact Kevin Knight 206-451-4823
media@lucirahealth.com
Investor Contact Greg Chodaczek 347-620-7010
investorrelations@lucirahealth.com
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