SAN DIEGO, Feb. 7, 2022 /PRNewswire/ -- Cue Health ("Cue")
(Nasdaq: HLTH), a healthcare technology company, today announced it
will provide Cue Health Monitoring Systems and Cue COVID-19 tests
to Johns Hopkins Medicine (JHM), which includes Johns Hopkins University School of Medicine and The
Johns Hopkins Hospital and Health System.
The portable monitoring system and tests will be utilized by
physicians, scientists, health professionals, faculty and staff as
part of JHM's commitment to health and well-being among its entire
employee population. In addition, JHM will have access to a Cue
Health Enterprise Dashboard, which allows for test results to be
shared through a secure, web-based internal application. This helps
organizations manage population health and access timely data and
analytics to enable administrators to swiftly identify trends and
make informed decisions.
Cue's test uses molecular nucleic acid amplification technology
(NAAT) and is the most accurate* self-test for COVID-19, providing
lab-quality results directly to connected mobile devices in 20
minutes. The test is able to detect all known COVID-19 variants,
including Omicron, and can be used on adults and children (age 2
years and over for OTC/home use and under 2 for professional use),
with or without symptoms.
"Johns Hopkins Medicine is playing a leading and critical role
in the fight against COVID-19, and we are honored to help support
their team's health and well-being," said Ayub Khattak, Co-Founder and CEO of Cue. "In
settings like hospitals and medical research facilities, accuracy
cannot be compromised and precision is paramount. That's why
world-class healthcare organizations like Johns Hopkins Medicine
turn to Cue. We provide the confidence in self-testing and access
to real-time health information that's highly valued for those on
the frontlines of this pandemic."
Johns Hopkins Medicine is one of several healthcare-affiliated
organizations to which Cue provides its tests, including
internationally-recognized hospital systems throughout the U.S..
Cue also provides tests to Google, the National Basketball
Association, and Major League Baseball, among other
organizations.
*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 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.
The Cue COVID-19 Test for Home and Over The Counter (OTC) Use
and the Cue COVID-19 Test (for professional use) 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.