SAN DIEGO, Nov. 29, 2021 /PRNewswire/ -- Cue Health
("Cue") (Nasdaq: HLTH), a healthcare technology company, today
announced it has completed an analysis of the SARS-CoV-2 B.1.1.529
variant, designated by the World Health Organization as Omicron.
Using information from the GISAID database, Cue has determined its
COVID-19 tests, which uses molecular (NAAT) technology, can detect
the Omicron variant. Specifically, Cue found that 99.2% of the
available 127 published sequences are a perfect match to the
primers used in the Company's tests. Cue's easy-to-use, portable
COVID-19 tests provide highly accurate, lab-quality results
directly to connected mobile smart devices in about 20 minutes, and
it can be used on adults and children (2 years and over), with or
without symptoms, wherever they are.
Cue's team of scientists and bioinformatic experts implemented a
surveillance program during the early stages of the pandemic to
monitor and analyze all relevant SARS-CoV-2 variant sequences
globally. These sequences are routinely compared to the primers in
Cue's COVID-19 test to determine if any mutations are present that
could affect the sensitivity or specificity of Cue's test.
Cue's tests work by targeting a region of the nucleocapsid gene (n
gene) that is highly conserved, and Company scientists have found
that the test's accuracy has remained unaffected by the mutations
in the Omicron variant and other variants of concern to date.
"Our molecular test is backed by the science and technology
necessary to detect emerging variants, including Omicron, enabling
individuals and healthcare practitioners to make better-informed
decisions," said Ayub Khattak,
Co-Founder and CEO of Cue. "Fast and accurate testing that is
bolstered by a scientist-led surveillance and monitoring system,
which identifies and analyzes variants in real time, will continue
to play a critical role in producing actionable health data,
preventing community spread and driving better outcomes."
Cue and Helix, a leading genomics company that provides
nationwide surveillance of respiratory disease, announced this
month a new collaboration to conduct a research study to evaluate
variant data. This sequencing effort will allow Cue to contribute
to public health sequencing and surveillance efforts by allowing
users who obtain positive COVID-19 test results at home to opt in
and consent to have their samples rapidly sequenced and shared with
public health sequencing repositories like GISAID. Cue's
collaboration with Helix further builds on Cue's previously
announced real-time variant tracking and sequencing solution, which
utilizes AI and ML from Google Cloud to add predictive capabilities
to the Cue platform.
Earlier this month, Cue launched its direct-to-consumer (DTC)
virtual health platform in the United
States, making Cue's first-of-its-kind molecular COVID-19
test available through Cue's new eCommerce site and in-app shop.
Cue's new membership offering — Cue+™ — offers members 24/7
on-demand access to board certified physicians, e-prescription
services, CDC-compliant test results for travel through in-app
video proctoring, and same-day delivery of Cue products in a number
of major markets.
In the U.S., the Cue COVID-19 Test for Home and Over The Counter
(OTC) Use was the first molecular test to receive FDA Emergency Use
Authorization (EUA) for at-home and over-the-counter use without a
prescription. This followed an EUA from the FDA in June 2020 for professional point-of-care use.
Internationally, Cue has received the CE mark in the European
Union for professional point-of-care use, Interim Order
authorization from Health Canada for both professional
point-of-care and consumer self-testing, and regulatory approval
from India's Central Drugs
Standard Control Organisation for professional point-of-care
use.
Cue has already delivered millions of COVID-19 tests, which are
being used in thousands of settings where a highly accurate,
no-compromise testing solution is required, including schools,
nursing homes, correctional facilities, hospitals, and community
health clinics, as well as in world-class organizations like Mayo
Clinic, Google, the National Basketball Association (NBA), and
Major League Baseball (MLB).
Cue aims to provide individuals with the ability to proactively
monitor and manage their health with actionable information that
they can share with healthcare providers in real-time. Cue's
planned future care offerings – all of which are intended to be
compatible with the Cue Reader – include products and services
across the categories of respiratory health (such as for influenza,
RSV, and strep throat), sexual health (such as for chlamydia and
gonorrhea), cardiac and metabolic health (such as for cholesterol
and HbA1c), women's and men's health, and chronic disease
management.
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, and
regulatory approval from India's
Central Drugs Standard Control Organisation. 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 the factors discussed in the "Risk Factors"
section of the Form 10-Q dated November 10, 2021 filed by Cue with the SEC. 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 COVID-19 Test for Home and Over The Counter (OTC)
Use and the Cue COVID-19 Test (for professional use) 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.