Cue Health Receives Singapore HSA Authorization for its Molecular COVID-19 Test for Self-Testing

Rhea-AI Summary

On December 1, 2021, Cue Health (Nasdaq: HLTH) announced it received Pandemic Special Access Route authorization from Singapore's Health Sciences Authority for its Cue COVID-19 Test, the first digital molecular diagnostic product authorized for home use in the country. This allows Cue to support public sector testing in Singapore through its partnership with Omnicell Pte Ltd. Cue plans to explore public and private partnerships to maximize the use of its diagnostic solutions. Additionally, Cue recently launched a direct-to-consumer health platform in the United States, offering a comprehensive health management solution.

Positive

• Received PSAR authorization for the Cue COVID-19 Test in Singapore, enabling immediate public sector use.
• First digital molecular diagnostic product authorized for home use in Singapore.
• Partnership with Omnicell Pte Ltd to enhance COVID-19 testing accessibility.
• Launched direct-to-consumer virtual health platform in the U.S. offering 24/7 access to healthcare services.

Negative

• None.

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.

"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.

 

View original content:https://www.prnewswire.com/news-releases/cue-health-receives-singapore-hsa-authorization-for-its-molecular-covid-19-test-for-self-testing-301435138.html

SOURCE Cue Health Inc.

FAQ

What is the significance of Cue Health's PSAR authorization in Singapore?

Cue Health's PSAR authorization allows its COVID-19 Test to be used for self-testing in Singapore, marking it as the first digital molecular diagnostic product approved for home use in the country.

How does Cue Health's partnership with Omnicell benefit COVID-19 testing in Singapore?

The partnership with Omnicell enables Cue Health to enhance the accessibility and efficiency of COVID-19 testing in Singapore by combining rapid antigen test speeds with PCR test accuracy.

What new services did Cue Health launch in the U.S.?

Cue Health launched a direct-to-consumer virtual health platform that provides members with 24/7 access to board-certified physicians and e-prescription services, among other health management features.

What does Cue Health aim to achieve through its partnerships in Singapore?

Cue Health aims to maximize the utilization of its Health Monitoring System and expand its testing offerings through public and private sector partnerships in Singapore.