SAN DIEGO and DUBLIN, Ohio, Feb. 17,
2022 /PRNewswire/ -- Today Cue Health Inc.
(Nasdaq: HLTH), a healthcare technology company, and Cardinal
Health (NYSE: CAH) announced expanded distribution of Cue's
professional use and over-the-counter COVID-19 tests.
Cue selected Cardinal Health, which serves nearly 90% of US
hospitals and over 60,000 pharmacies, as one of its primary
distributors due to a demonstrated expertise in helping
commercialize diagnostic technologies. This relationship will help
accelerate the reach of Cue's innovative nucleic acid amplification
test (NAAT) into both traditional and non-traditional healthcare
settings.
"Customers across the country trust Cardinal Health to deliver
high-quality laboratory products, and Cue shares a goal with them
of placing diagnostic information at the center of care," said
Ayub Khattak, Co-Founder and CEO of
Cue. "We look forward to making Cue's highly accurate, fast, and
easy-to-use testing and access to real-time health information more
widely available through our collaboration with Cardinal
Health."
Health professionals and other qualified point-of-care test
users can now purchase the Cue Health Monitoring System, the Cue
COVID-19 Test for CLIA Certified Healthcare Providers and
Laboratories (Professional), and Cue COVID-19 Test Positive Control
Swabs and Test Negative Control Swabs through the vast Cardinal
Health laboratory distribution network. An independent study by
Mayo Clinic showed Cue's COVID-19 test to be in 97.8% overall
concordance with central lab PCR testing.
Additionally, the Cue COVID-19 Test for Home and Over The
Counter (OTC) Use (OTC/Home) – the first molecular diagnostic test
of any kind available for use at home or in other non-clinical
settings without a prescription to receive Emergency Use
Authorization (EUA) from the FDA – is also available through
Cardinal Health. Cue's molecular OTC/home test is the most accurate
COVID-19 self-test*, can be used on adults and children (2 years
and over) with or without symptoms, and is available for use at
home or in other non-clinical settings without a prescription.
"Cue adds an important dimension to our suite of COVID-19
diagnostic solutions, further enhancing Cardinal Health's
comprehensive offering to meet our customers' evolving testing
needs," said Chris Kerski, Senior
Vice President and General Manager, Cardinal Health Laboratory
Products. "Cue's unique technology and platform combines molecular
testing with speed and convenience, meeting the demands of health
providers, employers, travelers, and others."
Both the professional and the OTC/home products will be
available in packs of 10 tests. The durable, rechargeable Cue
Health Monitoring System (Reader) communicates test results to the
user's connected mobile smart device in 20 minutes through the Cue
Health App, securely and conveniently.
In addition to highly accurate COVID-19 testing products, Cue
offers 24/7 on-demand virtual care from board-certified physicians
and in-app supervised testing through its Cue+™ membership program.
The proctored service provides certified results to help users meet
COVID-19 requirements for international air travel into
the United States, Canada, and many other countries.
Read more about Cardinal Health and Cue's COVID-19 OTC/Home test
here, as well as its COVID-19 professional test here.
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.
About Cardinal Health
Cardinal Health is a
distributor of pharmaceuticals, a global manufacturer and
distributor of medical and laboratory products, and a provider of
performance and data solutions for health care facilities. With 50
years in business, operations in more than 30 countries and
approximately 44,000 employees globally, Cardinal Health is
essential to care. Information about Cardinal Health is available
at cardinalhealth.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.
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.
*Based on clinical study results submitted to FDA for other
EUA molecular home tests.
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SOURCE Cue Health Inc.