SAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Cue Health
("Cue") (Nasdaq: HLTH), a healthcare technology company, today
announced it received Pandemic Special Access Route (PSAR)
authorization from the Health Sciences Authority (HSA) for the Cue
COVID-19 Test for self-testing in Singapore. The Cue COVID-19 Test is the first
natively digital molecular diagnostic product ever authorized for
consumer home use in Singapore.
Cue's partnership with Omnicell Pte Ltd allows Cue to immediately
begin supporting public sector use of the Cue COVID-19 Test.
![Cue_Health_Logo Cue_Health_Logo](https://mma.prnewswire.com/media/1442616/Cue_Health_Logo.jpg)
"We are excited to bring Cue's digitally connected, in-home
molecular diagnostics platform to Singaporean stakeholders and help
provide immediate access to critical health information. With Cue,
users will be able to make faster and more informed healthcare
decisions at a time when it's needed most," said Ayub Khattak, Co-Founder and CEO of Cue.
"Singapore as a country has been a
thought leader in adopting innovative healthcare technologies at
scale and has been a leading example for other APAC countries in
the region. Cue's HSA authorization sets the foundation for broad
application of the Cue platform in Singapore."
Omnicell Pte Ltd Regional Account Director Yoco Ting commented, "Testing remains an
important component in Singapore's
overall strategy for managing COVID-19. With the recent
authorization of the Cue COVID-19 Test via the Pandemic
Special Access Route, Omnicell is excited to bring forth into
Singapore the technological
advancement from Cue and further simplify the COVID-19 testing
process by now combining the speed of rapid antigen tests with the
lab-quality accuracy of PCR tests. We will continue to work closely
with local authorities and Cue to further the effort in controlling
COVID-19 in Singapore."
As the maker of the first and only natively digital molecular
diagnostics solution available in Singapore, Cue intends to explore both public
and private sector partnerships that Cue believes will further
enable the complete utilization of the Cue Health Monitoring System
for not only the Cue COVID-19 Test, but also Cue's future test menu
and other offerings.
Last 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.
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.