SAN
DIEGO, Aug. 24, 2022 /PRNewswire/ -- Cue Health
Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today
announced a new collaboration with Fresenius Kidney Care to provide
the most accurate* COVID-19 self-test to certain patients and
clinical care teams.
People who are immunocompromised have been disproportionately
affected by COVID-19 throughout the pandemic and remain highly
dependent on measures that reduce the likelihood of infections,
including vaccination. Cue can be used by vulnerable patient
populations and their care partners to detect and treat COVID-19
early, often before complications arise and hospitalization is
required. This is especially important in remote locations where
timely and accurate results are critical for making clinical
treatment decisions. Fresenius Kidney Care in Hawaii, Alaska, Puerto
Rico, Guam, and Saipan will
use the Cue Health Monitoring System and Cue COVID-19 Test to
screen employees and test symptomatic immunocompromised patients
in-center and at-home.
"This is a great example of how Fresenius Kidney Care is seeking
out the best technologies to ensure we do everything we can to
protect our vulnerable patient population from COVID-19," said
Ines Dahne-Steuber, President of
Spectra Laboratories, a Fresenius Medical Care company providing
laboratory diagnostics to dialysis centers across the country.
"This collaboration with Cue will help us provide patients with
greater access to high-quality timely diagnosis and care in our
effort to improve health outcomes while lowering costs."
Fresenius Kidney Care operates more than 2,600 dialysis centers
in the U.S., providing more than 200,000 patients annually with
services that include at-home peritoneal dialysis, at-home
hemodialysis, in-center hemodialysis, and additional clinical care
resources.
"By utilizing Cue's platform, Fresenius Kidney Care can continue
to provide its life-saving services to immunocompromised patients
with confidence they are using the most accurate COVID-19
self-test," said Ayub Khattak,
Chairman and CEO of Cue Health. "We treat accuracy as
non-negotiable so healthcare-affiliated organizations across the
country can continue to trust Cue for their testing needs in
high-stakes environments."
Fresenius Kidney Care is one of the growing number of
healthcare-affiliated organizations and internationally-recognized
hospital systems throughout the U.S working with Cue to transform
how diagnostic healthcare is delivered to close gaps in the patient
journey and drive improved health outcomes. Cue is used in many
other point-of-care settings such as Johns Hopkins Medicine and
Mayo Clinic, by world-class organizations across the country,
including Google, the National Basketball Association, and Major
League Baseball, and in homes.
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 subvariants of concern - including Omicron, BA.4, and
BA.5 - and can be used on adults and children (age 2 years and over
for over-the-counter (OTC) / home use and under 2 for professional
use), with or without symptoms.
*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 Cue's Annual Report on
Form 10-K for the year ended December 31,
2021 and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022 filed with the SEC on
August 10, 2022. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cue-health-provides-enhanced-care--protection-for-immunocompromised-populations--clinical-care-teams-at-fresenius-kidney-care-301611012.html
SOURCE Cue Health Inc.