SAN MATEO, Calif. and
SAN DIEGO, Nov. 18, 2021 /PRNewswire/ -- Helix, a
leading genomics company that provides nationwide viral
surveillance of respiratory disease, and Cue Health Inc. (Nasdaq:
HLTH), a healthcare technology company, announced a new
collaboration today to provide individuals who test positive on
Cue's at-home molecular COVID-19 test the opportunity to learn
which variant they have contracted as part of a broader research
study on the SARS-CoV-2 virus.
Despite the growing availability of vaccines in the United States, the need for more
consistent sequencing of the SARS-CoV-2 virus, and any future
respiratory viruses, continues to be significant as more contagious
strains like the Delta variant have resulted in new waves of
infections. This collaboration further builds on Cue's previously
announced real-time Variant Tracking and Sequencing Platform, which
will utilize AI and ML from Google Cloud. Cue Health and Helix
intend to roll out this new capability in the fourth quarter.
Cue users who receive a positive test result for COVID-19 will
be able to opt-in to SARS-CoV-2 variant sequencing. After
consenting to participate in this study, users will receive a
same-day sample collection kit with a prepaid return
shipper via Cue's last-mile delivery partners. The Cue Health
App will guide users through a simple, lower nasal swab
self-collection to obtain their sample for sequencing. Returned
samples will arrive at Helix for immediate processing, and results
from Helix will be shared with the individual through the Cue
Health App within ten days. This fully integrated and connected
workflow will help expedite sequencing information turnaround time,
while providing those tested with insight about their role in
pandemic response and containment.
"Cue's connected platform aims to empower people by providing
them with fast and convenient access to their health information.
Together with Helix, we can provide researchers with even more
information about what type of viral strain a person might have,
arming them with information to help prevent further viral spread
within our communities," said Ayub
Khattak, CEO and co-founder of Cue Health.
"We are excited to work with Cue Health to support COVID-19
testing and surveillance in a range of settings, from consumer to
clinic to community sites, and deliver those results at scale and
with speed," said James Lu, M.D.,
Ph.D., CEO and Co-founder of Helix.
The Helix variant sequencing test is for Research Use Only and
not yet authorized by the U.S. Food and Drug Administration (FDA)
for health care. The sequencing result provided is for the user's
information only and not to be used for medical decisions.
The United States has ranked
43rd in the world, in terms of overall sequences
performed and shared, according to Global Initiative on Sharing All
Influenza Data (GISAID). By collaborating, Helix and Cue Health can
help address the need for faster sequencing results by together
providing individuals with more comprehensive real-time access to
their personal health information, while increasing researchers'
awareness of known variant spread and new variants. This
sequencing effort will also allow Cue Health to contribute to the
public health sequencing efforts by uploading sequences to GISAID,
which is the largest data sharing repository of SarS-COV-2
sequencing data, relied upon by researchers, public health
entities, and others worldwide.
Cue Health's COVID-19 tests have been used by millions of people
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 Google, Mayo Clinic,
NASA, the NBA, and MLB. Cue's COVID-19 test can be used on adults
and children (2 years and over), with or without symptoms, wherever
they are.
Helix quickly established itself as one of the largest and most
capable labs in performing high-throughput diagnostic testing in
the US. Since spring of this year, Helix has focused its efforts on
viral surveillance in response to the need for more
comprehensive and consistent viral sequencing. Helix has analyzed
and reported on tens of thousands of COVID-19 viral sequences,
sharing information with CDC and state-level departments of health.
Helix also maintains a public viral surveillance dashboard on
its website and has published over a dozen pre-print and
peer-reviewed publications on viral sequences.
The companies expect that the research study will contribute
knowledge to help better understand pandemics and how they evolve
so as to improve pandemic readiness now and into the
future.
About Helix
Helix is the leading population genomics
company operating at the intersection of clinical care, research,
and genomics. Its end-to-end platform enables health systems, life
sciences companies, and payers to advance genomic research and
accelerate the integration of genomic data into clinical care.
Powered by one of the world's largest CLIA / CAP next-generation
sequencing labs and the first and only FDA authorized whole exome
sequencing platform, Helix supports all aspects of population
genomics including recruitment and engagement, clinically
actionable disease screening, return of results, and basic and
translational research. In response to the COVID-19 public health
crisis, Helix has launched a sensitive and scalable end-to-end
COVID-19 test and viral surveillance system to meet the needs of
health systems, employers, governments, and other organizations
across the country. Learn more at
www.helix.com.
About Cue Health
Cue Health (Nasdaq: HLTH) is a
healthcare technology company that puts consumers in control of
their 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 Health 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 prospectus dated
September 23, 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
has not been FDA cleared or approved; but has been authorized by
FDA under an EUA. This product has been authorized only for the
detection of nucleic acid from SARS-CoV-2, 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 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.