Reports Preliminary 2021 First Quarter Revenue
and Business Update
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
U.S. Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for over the counter (OTC) sale of the LUCIRA
CHECK IT™ test kit that delivers 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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210412005361/en/
The LUCIRA CHECK IT™ test kit provides
PCR quality, COVID-19 results in 30 minutes or less in the comfort
of home. (Photo: Business Wire)
This primarily U.S. designed and manufactured product 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 dramatically expands
the availability of this highly accurate test.
Each single-use test kit contains 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.
“We worked with more than 1,000 people before starting our FDA
clinical and usability studies. Our goal was to produce an
easy-to-use test that provides PCR quality accuracy in a portable,
intuitive, anytime, anywhere format,” said Lucira CEO Erik
Engelson. “People are looking for ways to feel more certain in
these uncertain times, and our Lucira CHECK IT test provides
that.”
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 over-the-counter 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 required 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.
Preliminary 2021 First Quarter Revenue and Business
Update
- Lucira expects net revenue for the three months ended March 31,
2021 of approximately $4.0 million to $4.5 million.
- Lucira added on-line ordering of its prescription product on
Lucira’s website in addition to other channels.
- First quarter 2021 results will be reported on May 13,
2021.
“The first quarter of 2021 was very fluid for Lucira, as the
rapid rollout of multiple COVID-19 vaccines, coupled with a
temporary inventory build of COVID-19 testing kits and an overall
slowdown in testing in the United States, hampered our growth in
the point of care,” said Lucira CEO Erik Engelson. “Despite the
dynamics that occurred in the first quarter, we believe our OTC
LUCIRA CHECK IT Test Kit is well-positioned to take advantage of
the shift to at home decentralized COVID-19 self-testing.”
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 financial results
(preliminary and unaudited) for the three months ended March 31,
2021. The data is not a comprehensive statement of Lucira’s results
for this period, and Lucira’s actual results may differ materially
from these preliminary estimated data. Lucira’s actual results
remain subject to the completion of management’s and Lucira’s audit
committee’s reviews and its other financial closing processes as
well as the completion and preparation of its financial data for
the three months ended March 31, 2021. During the course of the
preparation of such financial statements and related notes,
additional adjustments to the preliminary estimated financial
information presented below may be identified, and Lucira’s final
results for this period may vary from these preliminary estimates.
This preliminary estimated data should not be considered a
substitute for the financial statements to be prepared in
accordance with accounting principles generally accepted in the
United States and filed with the Securities and Exchange Commission
(SEC). Accordingly, you should not place undue reliance on these
preliminary data. Further, as forward-looking 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 “expects,” “plans,” “believe,” “will”,
“anticipates,” “goal,” “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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210412005361/en/
Investor Contact Greg Chodaczek 347-620-7010
investorrelations@lucirahealth.com
Media Contact Kevin Knight 206-451-4823
media@lucirahealth.com
Lucira Health (NASDAQ:LHDX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Lucira Health (NASDAQ:LHDX)
Historical Stock Chart
From Sep 2023 to Sep 2024