Cue Health Makes De Novo Submission to FDA for Full Clearance of its Cue® RSV Molecular Test
May 09 2023 - 9:15AM
Business Wire
Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology
company, today announced that it has made a De Novo submission to
the U.S. Food and Drug Administration (FDA) for full clearance of
the Cue RSV Molecular Test for at-home and point-of-care use. There
are currently no respiratory syncytial virus (RSV) tests on the
market for home use. Pending FDA clearance, Cue’s test would
provide the public, for the first time, an at-home molecular RSV
test to use on people of all ages that has been fully reviewed by
the FDA for safety and effectiveness.
RSV is a common, seasonal respiratory virus that can be serious,
especially for infants and older adults. It is the most common
cause of bronchiolitis and pneumonia in children younger than 1
year of age in the United States. According to the CDC, RSV leads
to 2.1 million outpatient hospital visits per year among children
younger than 5 years old and 58,000-80,000 hospitalizations among
that age group. Additionally, RSV leads to between 60,000-160,000
hospitalizations each year among adults 65 years and older.
“Both young children and older adults are at high risk for
severe RSV infection, which includes symptoms similar to the flu,
COVID-19, and the common cold, but has a distinct plan for managing
care,” said Dr. David Tsay, Chief Medical Officer for Cue Health.
“This makes early detection of the virus even more important to
lower the risk of a severe infection, especially among high-risk
populations.”
The Cue RSV Molecular Test Cartridge uses a lower nasal swab and
is compatible with the Cue Reader, which communicates test results
digitally via Bluetooth to a mobile device in approximately 25
minutes.
Ayub Khattak, Chairman and CEO of Cue Health, added, “With our
submission to the FDA, we are one key step closer to providing a
user-friendly, advanced molecular RSV test that has the potential
to be a landmark new tool to manage the threat of RSV, which is the
leading cause of hospitalization of young children and a
significant risk to the elderly.”
Earlier this month, the FDA approved the first RSV vaccine for
individuals 60 years of age and older and three other RSV vaccines
for older adults are in the final phases of testing. Additionally,
earlier this year, the FDA granted Fast Track designation for an
RSV treatment to accelerate its development and review.
Cue has an installed base of more than a quarter million Cue
Readers and continues to make progress to advance a wide range of
future diagnostic tests and related services that are compatible
with this system. Cue's COVID-19 test was the first FDA-authorized
molecular diagnostic test for at-home and over-the-counter use
without a prescription, which is currently under De Novo review
with the FDA.
Earlier this year, Cue received Emergency Use Authorization
(EUA) from the FDA for its molecular mpox (monkeypox) test. The
company has submitted an application to the FDA for an EUA for its
Cue Flu + COVID-19 Molecular Test. Cue’s standalone molecular Flu
test is also under De Novo review with the FDA for full
clearance.
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. 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.
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