Cue's molecular COVID-19 self-test provides lab-quality
results in 20 minutes
SAN DIEGO, March 16, 2022 /CNW/ -- Cue Health ("Cue")
(Nasdaq: HLTH), the healthcare technology company behind
the most accurate at-home COVID-19 test* in the U.S., today
announced that its molecular COVID-19 test is now available to
individual consumers in Canada.
The Cue Health Monitoring System (Reader) and Cue's molecular
COVID-19 test for home, can be accessed through Cue's eCommerce
site and in-app shop. Canadian consumers can also sign up for the
Cue+ Foundation membership, which provides users with unlimited
access to Cue's supervised COVID-19 test by virtual proctor in
English and French for travel, work, or school; ten (10) COVID-19
tests are included in each membership, as well as ongoing discounts
on Cue products.
Cue has received Interim Order authorization from Health Canada
to sell and distribute its COVID-19 test for both professional use
at the point-of-care and consumer self-testing. Cue's test
uses molecular nucleic acid amplification technology (NAAT),
providing lab-quality results directly to connected mobile devices
in 20 minutes. The test can detect all known COVID-19 variants and
can be used on adults and children (ages 2 and over), with or
without symptoms. The supervised test meets current COVID-19
testing entry requirements for international travel in many
countries around the world, including Canada and the U.S., and the results are also
often accepted by employers, schools, and sports and entertainment
venues.
"Following the successful launch of our smart home lab platform
in the U.S., we are pleased to now offer Canadian consumers access
to our molecular COVID-19 self-test that combines accuracy, speed,
and reliability," said Ayub Khattak,
co-founder and CEO of Cue Health. "Canadians will now have a more
convenient molecular testing solution that gives them accurate
results when they want peace of mind or to protect their loved
ones, when traveling, returning to work, or visiting entertainment
and sports venues."
Last year, Cue announced a partnership with Air Canada to
provide U.S.-based passengers with access to Cue's molecular
COVID-19 test for their travel needs. Cue also provides tests to
other world-class organizations like Johns Hopkins Medicine, Mayo
Clinic, Google, the National Basketball Association (NBA), and
Major League Baseball (MLB), among many others. Looking ahead, Cue
is working on new diagnostic tests - including for other
respiratory illnesses, sexual diseases, women's and men's health,
cardiometabolic health, and more - all of which will be compatible
with the connected Cue Reader.
*Based on clinical study results submitted to FDA for other
EUA molecular home tests.
About Cue Health
Cue Health (Nasdaq: HLTH) is a healthcare technology company
that makes it easy for individuals to access health information and
places diagnostic information at the center of care. Cue Health
enables people to manage their health through real-time,
actionable, and connected health information, offering individuals
and their healthcare providers easy access to lab-quality
diagnostics anywhere, anytime, in a device that fits in the palm of
the hand. Cue Health's first-of-its-kind COVID-19 test was the
first FDA-authorized molecular diagnostic test for at-home and
over-the-counter use without a prescription and physician
supervision. Outside the United
States, Cue Health has received the CE mark in the European
Union, Interim Order authorization from Health Canada, regulatory
approval from India's Central
Drugs Standard Control Organization, and PSAR authorization from
Singapore's Health Sciences
Authority. Cue was founded in 2010 and is headquartered in
San Diego. For more information,
please visit www.cuehealth.com.
Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
"forward-looking statements". The words, without limitation,
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "predict," "project,"
"should," "target," "will," "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these or similar identifying
words. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including those related to the expected future diagnostic
test menu and the factors discussed in the "Risk Factors" section
of the Form 10-Q dated November 10,
2021 filed by Cue with the SEC. Any forward-looking
statements contained in this press release are based on the current
expectations of Cue's management team and speak only as of the date
hereof, and Cue specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
This product is authorized for sale or importation in
Canada pursuant to section 5 of
the Interim Order Respecting the Importation and Sale of Medical
Devices for Use in Relation to COVID-19, made by the Minister of
Health on March 18, 2020 and the
subsequent Interim Order No. 2 on March 1,
2021.
In the United States, these
products have not been FDA cleared or approved; but have been
authorized by FDA under an Emergency Use Authorization (EUA). These
products have been authorized only for the detection of nucleic
acid from SARS-CoV-2, not for any other viruses or pathogens. The
emergency use of these products is only authorized for the duration
of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
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SOURCE Cue Health Inc.