SAN
DIEGO, Sept. 1, 2022 /PRNewswire/ -- Cue Health
("Cue") (Nasdaq: HLTH) today announced that it has made a de
novo submission to the U.S. Food and Drug Administration (FDA)
for full clearance of the Cue® Flu Molecular Test for at-home and
point-of-care (POC) use. There are currently no flu tests on the
market for home use. FDA clearance of Cue's test would provide the
public, for the first time, an at-home and POC molecular flu test
that has been fully reviewed by the FDA for safety and
effectiveness.
Clinical study results with the Cue Flu Molecular Test were
favorable, demonstrating 99% accuracy1 compared to
FDA cleared molecular (PCR) laboratory tests for influenza A&B.
The Cue Flu Molecular Test cartridge uses a lower nasal swab and is
compatible with the Cue Reader, which communicates test results
digitally via Bluetooth to a mobile device in approximately 25
minutes.
"This FDA submission for our Cue Flu Molecular Test is another
important milestone on Cue's path to pioneer a new approach to
diagnostics in homes, enterprises, and healthcare settings," said
Ayub Khattak, Chairman and CEO of
Cue Health. "Early detection and treatment can meaningfully improve
health outcomes. There are multiple FDA-approved antiviral
treatments for influenza available today, and we expect we will
soon be able to promptly get these medications into the hands of
patients who need them thanks to our recently launched Cue Care
service."
Cue's molecular COVID-19 test, which is authorized by the FDA
for home and POC use under an Emergency Use Authorization (EUA), is
also currently under de novo review with the FDA. With an
installed base of over a quarter million Cue Readers shipped to
date, Cue's COVID-19 test has been used by millions of Americans.
Cue is used by some of the nation's leading healthcare
institutions, including Johns Hopkins Medicine, Mayo Clinic,
Memorial Hermann, and UPMC Children's Hospital of Pittsburgh. Cue is also used by world-class
organizations such as Major League Baseball, Google, the National
Basketball Association, Bridgewater, among others.
About Cue Health
Cue Health (Nasdaq: HLTH) is a
healthcare technology company that makes it easier 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.
Cue's COVID-19 tests have not been FDA cleared or approved;
but have been authorized by FDA and 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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1 With discordance
analysis using a second FDA-cleared laboratory PCR test
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SOURCE Cue Health Inc.