Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use
03 Agosto 2023 - 5:22PM
Business Wire
The test will be designed to detect and
differentiate between the four viruses and deliver results in
approximately 25 minutes
Cue Health (Nasdaq: HLTH), a healthcare technology company,
today announced that it has been awarded a new approximately $28
million contract by the Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response within the U.S. Department of
Health and Human Services (HHS), to develop a Flu A/B, RSV, and
COVID-19 molecular multiplex test for both over-the-counter (OTC)
and point-of-care (POC) use. Cue’s test would detect and
differentiate between influenza A, influenza B, respiratory
syncytial virus (RSV), and COVID-19 simultaneously, with results
delivered in approximately 25 minutes to connected smart
devices.
The company has also applied with the U.S. FDA for Emergency Use
Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for
at-home and point-of-care (POC) use. Cue also requested De Novo
classification from the FDA for the Cue RSV Molecular Test for
at-home and point-of-care use. In March, the company received an
EUA from the FDA for the Cue Mpox (Monkeypox) Molecular Test, which
can be performed at the point-of-care at any CLIA-waived
facility.
Influenza, RSV, and COVID-19 are common respiratory viruses that
can be serious, especially for older adults, those with weakened
immune systems, and infants. Combined, these viruses are
responsible for hundreds of thousands of hospitalizations each
year. RSV is the leading cause of hospitalization among children
less than one year of age in the U.S. The flu alone caused between
27 million and 54 million illnesses last respiratory season
(2022-2023), according to the Centers for Disease Control and
Prevention (CDC). And approximately 7,000 people are still admitted
to the hospital per week due to COVID-19 in the U.S, per CDC data
as of July 15, 2023.
“By expanding our successful partnership with BARDA, we’re able
to meet a critical health need by utilizing Cue’s diagnostic
platform to detect and differentiate between some of the most
common respiratory viruses that have similar symptoms but distinct
treatment options,” said Ayub Khattak, Chairman and CEO of Cue
Health. “We expect this test will arm individuals and their
providers with actionable information that can reduce community
spread, increase the efficacy of treatment, and help lead to better
health outcomes. We’re honored to be called upon once again to
partner with BARDA to strengthen the nation’s emergency
preparedness, and in doing so, empower more people to live their
healthiest lives.”
Cue was awarded a contract by BARDA in 2020 to accelerate the
development, validation, and FDA clearance of its COVID-19 test,
which was the first molecular test to receive FDA Emergency Use
Authorization for at-home and over-the-counter use without a
prescription. Cue also recently received De Novo authorization from
the FDA for the same COVID-19 test (Cue COVID-19 Molecular Test),
which was the first De Novo granted for any home use respiratory
test available without a prescription. Cue’s work with BARDA began
in 2018 when the company received base funding to accelerate the
development and regulatory validation of over-the-counter and
professional use flu test cartridges, the Cue Health Monitoring
System, and cartridge manufacturing technology.
The Cue molecular tests all run on the Cue Health Monitoring
System (Reader), which has an installed base of more than a quarter
million. Cue’s molecular tests are manufactured at its San Diego
headquarters, where production and assembly lines have the built-in
capability to pivot between manufacturing different Cue diagnostic
tests in near real-time.
This project is being funded in whole or in part with federal
funds from the Department of Health and Human Services;
Administration of Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority, under contract number
75A50123C00036.
About Cue Health
Cue Health Inc. (Nasdaq: HLTH) is a healthcare technology
company that uses diagnostic-enabled care to empower people to live
their healthiest lives. The Cue Health platform offers individuals
and healthcare providers convenient and personalized access to
lab-quality diagnostic tests at home and at the point-of-care, as
well as on-demand telehealth consultations and treatment options
for a wide range of health and wellness needs. Cue’s customers
include federal and state public sector agencies and the private
sector, which includes healthcare providers, enterprises, and
individual consumers. Cue received De Novo authorization from the
U.S. Food and Drug Administration (FDA) for its COVID-19 test,
which became the first home use respiratory test to receive this
FDA approval. Cue also received Emergency Use Authorization from
the FDA for its molecular mpox test at the point-of-care. To
further expand its test menu, Cue has made other submissions that
are now under review by the FDA, including for the Cue® Flu +
COVID-19 Molecular Test and the Cue® RSV Molecular Test, both of
which are designed for at-home and point-of-care use. Cue, founded
in 2010, owns over 100 patents 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, including those regarding Cue’s diagnostic
platform, its partnership with BARDA, and statements made by Cue’s
CEO, 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,
2022 filed with the SEC on March 16, 2023 and Cue’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2023 filed with
the SEC on May 10, 2023. 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 Mpox (Monkeypox) Molecular Test has not been FDA cleared
or approved, but has been authorized for emergency use by FDA under
an EUA. This product has been authorized only for the detection of
nucleic acid from monkeypox virus, not for any other viruses or
pathogens. The emergency use of this product 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 infection with the monkeypox virus,
including in vitro diagnostics that detect and/or diagnose
infection with non-variola Orthopoxvirus, under Section 564(b)(1)
of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
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