Cue Health Achieves Groundbreaking Milestone with FDA: First Company to Receive De Novo Authorization for a COVID-19 Home Use Test
June 06 2023 - 3:49PM
Business Wire
Cue’s COVID-19 Molecular Test detects all
known variants of concern and seamlessly integrates with Cue Care,
the company’s innovative test-to-treatment platform
Cue Health (Nasdaq: HLTH), a healthcare technology company,
announces an industry breakthrough as the first company to receive
De Novo authorization from the U.S. Food and Drug Administration
(FDA) for its Cue COVID-19 Molecular Test, designed for both home
and point-of-care use. This sets a new standard as the first FDA De
Novo authorization for a home use COVID-19 test and the first De
Novo granted for any home use respiratory test.
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This significant achievement highlights Cue Health's dedication
to empowering individuals with accurate, accessible, and actionable
diagnostic tools. The FDA's De Novo authorization signifies that
the Cue COVID-19 Molecular Test meets the agency's stringent
regulatory standards for safety and efficacy.
Originally made available to consumers without a prescription
through a 2021 FDA Emergency Use Authorization (EUA), Cue's
COVID-19 test delivers results in just 20 minutes to connected
mobile smart devices. With a demonstrated overall accuracy of 98%,
the test detects all known COVID-19 variants of concern and
integrates into Cue Care, the company's state-of-the-art
test-to-treatment service.
Ayub Khattak, Chairman and CEO of Cue Health, said, "We are
honored to receive this landmark De Novo authorization from the
FDA, which emphasizes the reliability and accuracy of our COVID-19
Molecular Test in home and point-of-care settings. Our integrated
test-to-treatment platform, coupled with the recent authorization
of our mpox test and several other molecular tests under FDA review
or in clinical studies, helps enable faster and better-informed
healthcare decisions while making care and treatment more
convenient."
This project has been funded in whole or in part with federal
funds awarded by the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority, beginning in June 2018
under contract number HHSO100201800016C.
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’s COVID-19 test was the first
FDA-authorized molecular diagnostic test for at-home and
over-the-counter use without a prescription. Cue has since received
Emergency Use Authorization from the FDA for its molecular mpox
test at the point of care and, to expand its test menu, the company
has a number of other submissions under review by the FDA. 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, 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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