Peer-Reviewed Independent Study Published in Microbiology Spectrum Finds Cue Health’s Molecular COVID-19 Test is as Accurate as a Lab-Based PCR Test
04 Outubro 2023 - 10:15AM
Business Wire
In largest-of-its-kind clinical study on
asymptomatic people, Cue demonstrated 99.4% accuracy compared to
lab-based PCR
Cue Health (Nasdaq: HLTH), a healthcare technology company,
announced today the peer-reviewed publication of an independent
clinical study - the largest of its kind on asymptomatic people -
finding that Cue’s molecular COVID-19 test provides comparable
accuracy to centralized lab-based RT-PCR with the advantages of
convenient use at the point-of-care or home settings and fast
results in 20 minutes.
The study, published in Microbiology Spectrum, a journal
produced by the American Society for Microbiology, presents
findings from a head-to-head comparison of the Cue COVID-19 test
against lab-based RT-PCR on paired samples from 3,037 individuals.
The findings from paired testing revealed a 99.4% match between
results from Cue’s test and the reference PCR tests with 100%
clinical sensitivity to detect positive cases, yielding no false
negatives. The finding of high test sensitivity in the primarily
asymptomatic patient population (98.7%) highlights Cue’s accuracy
for detection at varying stages of infection and viral load, a
critical diagnostic feature that supports early identification and
robust risk mitigation.
The publication also presents analysis of Cue COVID-19 testing
and operational metrics for 13,848 individuals who accessed the
direct to consumer (private pay) COVID-19 Express Testing Services
at seven clinics located in urban centers in Ontario, Canada
between July 17, 2021 and January 31, 2022, under the Health Canada
emergency use authorization framework. The diverse testing
population included patrons with ages ranging from under 1 year to
over 60 years. Specimen collection and Cue COVID-19 testing was
performed by trained registered nurses (RNs and RPNs) and RT-PCR
was performed at the FH Health Laboratory, which is licensed by the
Ontario Ministry of Health and accredited under ISO 15189 for
COVID-19 diagnostic testing.
“Rapid and accurate COVID-19 asymptomatic screening has been
challenging due to the poor sensitivity of antigen testing and the
delays with lab-based PCR testing,” said Dr. Anu Rebbapragada,
D(ABMM) FCCM, Lead Investigator, Laboratory Director & VP
Diagnostic Services at FH Health. “The findings from our large
testing population indicate that sensitivity of Cue’s POC testing
may be an excellent proxy for PCR when accurate and fast results
are urgently needed to curb transmission.”
Dr. Rebbapragada further noted in the paper that the combination
of high sensitivity and quick turnaround time for results (20
minutes) offer critical benefits to screening programs utilizing
Cue’s COVID-19 test:
- Reduce the likelihood of spread in gatherings, including
workplace settings, providing confidence when testing asymptomatic
individuals;
- Facilitate earlier access to treatment, promoting timely
clinical management and intervention with antivirals;
- Maintain cost-effectiveness and efficiency by avoiding the
logistics and infrastructure needed for lab-based PCR tests and the
frequent re-screening needed with lower sensitivity antigen
tests.
“COVID-related hospital admissions are on the rise across the
U.S., demonstrating the ongoing need for vigilance, especially to
protect high risk individuals such as the elderly and
immunocompromised, and that begins with access to highly accurate,
fast, and reliable testing,” said Dr. David Tsay, Chief Medical
Officer at Cue. “This study finds Cue’s test has accuracy
comparable to that of central laboratory PCR, while being fast and
easy-to-use in the point-of-care setting.”
Cue recently 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.
To further expand its diagnostic test menu for at-home and
point-of-care use, Cue has made a number of other submissions with
the FDA.
Cue did not provide funding or any other support of the
study.
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 A/B + 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 June 30, 2023 filed with the SEC on August 9, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231003251430/en/
press@cuehealth.com
Cue Health (NASDAQ:HLTH)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
Cue Health (NASDAQ:HLTH)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024