In largest-of-its-kind clinical study on asymptomatic
people, Cue demonstrated 99.4% accuracy compared to lab-based
PCR
SAN
DIEGO, Calif., Aug. 17,
2022 /PRNewswire/ -- Cue Health Inc. ("Cue")
(Nasdaq: HLTH) announced today the preprint publication of an
independent clinical study - the largest of its kind on
asymptomatic people - demonstrating that its point of care (POC)
molecular COVID-19 test, which produces results in approximately 20
minutes, is as accurate as a centralized lab-based RT-PCR.
The study 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 revealed a 99.4% match between
results from Cue's test and the reference PCR tests, including 100%
clinical sensitivity to detect positive cases, yielding no false
negatives. Of this testing population, 98.7% was asymptomatic at
varying stages of infection and viral load.
"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 and Laboratory Director at FH Health, who was
responsible for diagnostic testing and the analysis of results for
this manuscript. "The findings from our large study 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 due to its high
sensitivity and quick turnaround time for results (approximately 20
minutes), screening programs utilizing Cue's COVID-19 test can:
- 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.
"We're proud of the results of this study, which further
validates that with Cue, you can achieve diagnostic testing that is
accurate, fast, and convenient," added Andy
Hudak, VP of Research & Development and Program
Management at Cue Health. "As the study demonstrates, the high
sensitivity of Cue's testing platform can quickly identify
asymptomatic cases allowing for large groups, such as in the
workplace, to gather safely."
The FH Health analysis included results from 13,848 individuals
who accessed the private (fee for service) COVID-19 Express Testing
Services at seven FH Health clinics located in urban centers in
Ontario, Canada between
July 17, 2021 and January 31, 2022. The diverse testing population
ranged in age from infants to seniors. Specimen collection and Cue
COVID-19 testing was performed by trained registered nurses (RNs
and RPNs) at FH Health clinic sites. 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. Cue did not provide funding or any other support of the FH
Health Study.
Cue's COVID-19 test has been authorized for use in the United States by FDA under Emergency Use
Authorizations (EUA) for professional use at the point-of-care by
healthcare providers and certified laboratories as well as for
over-the-counter use. It is also authorized for use in Canada through Interim Order authorization
from Health Canada.
About Cue Health
Cue Health (Nasdaq: HLTH) is a
healthcare technology company that makes it easy 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 June 30,
2022 filed with the SEC on August 10,
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.
These products have not been FDA cleared or approved; but
have been authorized by FDA 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.
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SOURCE Cue Health Inc.