SAN
DIEGO, May 2, 2022 /PRNewswire/ -- Cue
Health ("Cue") (Nasdaq: HLTH) today became the first company to
submit to the U.S. Food and Drug Administration (FDA) for full
clearance of its molecular COVID-19 test for at-home and
point-of-care use. FDA clearance would provide the public with a
molecular COVID-19 test that has been fully reviewed by the FDA for
safety and effectiveness.
A prior submission to the FDA for Emergency Use Authorization of
Cue's COVID-19 at-home, over-the-counter test showed 98.9%
accuracy. An independent study by Mayo Clinic showed Cue's COVID-19
test to be in 97.8% overall concordance with central lab PCR
testing.
"This FDA submission marks a major milestone for the company and
begins to define a new space of molecular testing in the home and
at the point-of-care. We hope this will be the first of many
submissions for Cue's molecular testing as we look to address a
range of diseases and conditions and make healthcare more
responsive, convenient, and effective," said Ayub Khattak, CEO and co-founder of Cue
Health.
With an installed base of nearly a quarter million Cue
Readers to date, Cue's COVID-19 test has been used by millions of
Americans. Cue is a COVID-19 testing solution in a number 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, and the National Basketball Association.
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-K dated March 29, 2022
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.
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SOURCE Cue Health Inc.