SAN DIEGO, Jan. 6, 2022 /PRNewswire/ -- Cue Health ("Cue")
(Nasdaq: HLTH), a healthcare technology company, today announced it
will develop an Omicron-Genotyping COVID-19 test to be used in
professional point-of-care settings as part of the company's
ongoing work with the U.S. Department of Health and Human Services'
Biomedical Advanced Research and Development Authority (BARDA)
within the Office of the Assistant Secretary for Preparedness and
Response. The Omicron-specific test will complement Cue's existing
highly-accurate, molecular COVID-19 test, which can detect all
known COVID-19 variants, including Omicron, a finding announced by
the company in November.
The additional funding from BARDA will be used to accelerate the
development, validation, and regulatory authorization of a
single-plex assay designed solely to detect the Omicron variant in
nasal samples. The new test will be compatible with the Cue Health
Monitoring System and the Cue Health Mobile Application.
"An Omicron-specific test will assist clinicians in providing
patients better treatment options and containment strategies at the
time of a positive diagnosis," said Ayub
Khattak, Co-Founder and CEO of Cue. "We are proud to partner
with BARDA to develop this new test, which will help eliminate
guesswork, provide more choices for patients, and strengthen public
health outcomes for communities."
Cue has worked with BARDA since 2018, when the Company received
$30 million in base funding to
accelerate the development and regulatory validation of
over-the-counter and professional use Influenza and Multiplex
Respiratory Pathogen diagnostic cartridges for the Cue Health
Monitoring System. In March 2020, Cue
was awarded $13 million by BARDA to
accelerate the development, validation, and FDA clearance of a
portable, molecular diagnostic test capable of detecting
SARS-CoV-2. Cue received Emergency Use Authorization (EUA) from the
FDA in June 2020 for professional
point-of-care use of its COVID-19 test. In March 2021, Cue was the first molecular test to
receive FDA authorization for at-home and over-the-counter use
without a prescription.
During the early stages of the pandemic, Cue's team of
scientists and bioinformatic experts implemented a surveillance
program to monitor and analyze all relevant SARS-CoV-2 variant
sequences globally. These sequences are routinely compared to the
primers in Cue's COVID-19 test to determine if any mutations are
present that could affect the sensitivity or specificity of Cue's
test. Cue's tests work by targeting a region of the nucleocapsid
gene (n gene) that is highly conserved, and Company scientists have
found that the test's accuracy has remained unaffected by the
mutations in the Omicron variant and other variants of concern to
date.
Cue 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 and can be used on adults and children (2 years and over),
with or without symptoms, wherever they are.
*Based on clinical study results submitted to FDA for other
EUA molecular home tests.
This project has been funded in whole or in part with federal
funds from the U.S. Department of Health and Human Services' Office
of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority, under
Contract No. HHSO100201800016C.
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.