Cue Health Receives FDA Emergency Use Authorization for Molecular Mpox Test
March 20 2023 - 9:15AM
Business Wire
Authorized to be used in professional
point-of-care settings, the nucleic acid amplification test
can detect mpox virus and deliver results in 25 minutes
Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology
company, today announced it has received Emergency Use
Authorization (EUA) from the United States Food and Drug
Administration (FDA) for its molecular test to detect the mpox
virus (formerly known as monkeypox). This nucleic acid
amplification test (NAAT) is run on a Cue Reader, can be performed
at any CLIA-waived facility and delivers results in 25 minutes,
significantly expanding access to fast and accurate testing for
patients.
This EUA marks an important milestone for Cue Health, as it is
the company’s first non-COVID test to receive FDA authorization, as
well as its initial offering in the sexual health category for
point-of-care diagnostics. The authorization demonstrates the
diverse applications of the Cue Health Monitoring System, proving
its capability to address a wide range of testing needs.
Like all tests developed by Cue, the Cue Mpox Molecular Test was
designed with ease-of-use in mind. The test simply requires using a
Cue Sample Wand to collect a lesion sample or to dip into a viral
transport medium (VTM) containing a specimen. The Cue Sample Wand
is then inserted into the Cue Cartridge, which has been placed
inside the Cue Reader. Results are delivered to a mobile device in
25 minutes. The test demonstrated high accuracy in trials,
achieving 100% concordance with the CDC’s mpox test on the clinical
samples tested.
"At Cue, we are committed to developing innovative diagnostic
solutions that empower both patients and healthcare providers with
accurate and timely results," said Ayub Khattak, CEO of Cue Health.
"The FDA EUA for our Mpox Molecular Test provides a great tool for
clinicians and their patients and demonstrates our platform's
versatility."
Mpox is a highly contagious and potentially severe viral
infection that has recently emerged as a global health concern.
With symptoms ranging from fever and fatigue to severe skin
eruptions and respiratory distress, early and accurate detection of
mpox is crucial in controlling its spread and providing timely
medical intervention.
With a diverse suite of tests utilizing the same diagnostics
platform currently under FDA review and in development, Cue Health
continues to innovate and expand its product offerings. Cue'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. The company has since submitted an
application to the FDA for an EUA for its Cue Flu + COVID-19
Molecular Test. In addition, Cue’s standalone molecular tests for
both flu and COVID-19 are under de novo review with the FDA for
full clearance. Cue also expects to submit its RSV, strep throat,
and chlamydia + gonorrhea multiplex tests to the FDA for review
later this year. With an installed base of more than a quarter
million Cue Readers, Cue’s COVID-19 test has been used by millions
of Americans and has become a go-to solution for accuracy, speed,
and convenience.
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
September 30, 2022 filed with the SEC on November 9, 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.
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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