SAN DIEGO, November 29, 2021 / PRNewswire / – Cue Health (“Cue”) (Nasdaq: HLTH), a health technology company, announced today that it has completed an analysis of SARS-CoV-2 B.1.1.529 as named by the World Health Organization Omicron. Using information from the GISAID database, Cue has determined that its COVID-19 tests, which use molecular (NAAT) technology, can detect the Omicron variant. In particular, Cue found that 99.2% of the 127 published sequences available were a perfect match for the primers used in the company’s tests. Cue’s easy-to-use, portable COVID-19 tests deliver highly accurate, laboratory-quality results in around 20 minutes directly on connected smart mobile devices and can be used on adults and children (2 years and older) with or without symptoms, wherever they are.
Cue’s team of scientists and bioinformaticians carried out a surveillance program in the early stages of the pandemic to monitor and analyze all relevant sequences of SARS-CoV-2 variants worldwide. These sequences are routinely compared to the primers in Cue’s COVID-19 test to determine if there are any mutations that could affect the sensitivity or specificity of the Cue test. Cue’s tests target a highly conserved region of the nucleocapsid gene (n-gene).
“Our molecular test is backed by the science and technology needed to detect new variants, including Omicron, and enables individuals and clinicians to make better informed decisions.” called Ayub Khatak, Co-Founder and CEO of Cue. “Fast and accurate testing, backed by a scientist-led surveillance and monitoring system that identifies and analyzes variants in real time, will continue to play a critical role in creating actionable health data, preventing community spread and achieving better results. “
Cue and Helix, a leading genomics company providing national respiratory disease monitoring, announced A new collaboration this month to conduct a research study to evaluate variant data. These sequencing efforts will allow Cue to contribute to public health sequencing and surveillance efforts by allowing users who receive positive COVID-19 test results at home to sign up and consent to their samples being quickly sequenced and sent to sequencing repositories public health such as GISAID. Cue’s collaboration with Helix builds on cues from previous collaborations announced Real-time variant tracking and sequencing solution that leverages Google Cloud’s AI and ML to add prediction 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 molecular COVID-19 test available through Cue’s new eCommerce site and in-app shop. Cue’s new membership offering – Cue + ™ – provides members with 24/7 on-demand access to government-certified doctors, e-prescribing services, CDC-compliant test scores for travel through in-app video surveillance, and same-day delivery of Cue products in a number of important markets.
In the United States, the Cue COVID-19 Home and Over-the-Counter (OTC) test was the first molecular test to receive FDA Emergency Approval (EUA) for home and over-the-counter use without a prescription. This followed an EEA from the FDA in June 2020 for professional point-of-care use.
Internationally, Cue has the CE mark in the European Union for professional point-of-care use, Health Canada provisional approval for professional point-of-care and consumer self-tests, and regulatory approval for. obtain India Central Drugs Standard Control Organization for professional use at the point of care.
Cue has delivered millions of COVID-19 tests used in thousands of environments where a high-precision, no-compromise testing solution is required, including schools, nursing homes, correctional facilities, hospitals and community health clinics, e.g. in world-class organizations such as Mayo Clinic, Google, the National Basketball Association (NBA) and Major League Baseball (MLB).
Cue aims to empower individuals to proactively monitor and manage their health, with actionable information they can share with healthcare providers in real time. Cue’s planned future care offerings – all of which should be compatible with the Cue Reader – include products and services in the categories of respiratory health (such as the flu, RSV and strep throat), sexual health (such as chlamydia and gonorrhea), heart and metabolic health (such as for Cholesterol and HbA1c), Women’s and Men’s Health, and Treatment of Chronic Diseases.
About Cue Health
Cue Health (Nasdaq: HLTH) is a health technology company that makes health information easier for individuals and puts diagnostic information at the heart of treatment. Cue Health enables people to manage their health through actionable and connected health information in real time, providing individuals and their healthcare providers with easy access to laboratory-quality diagnostics anywhere, anytime with a device that fits in the palm of your hand. Cue Health’s first COVID-19 test was the first FDA-cleared molecular diagnostic test for home and over-the-counter use without a prescription and medical supervision. Outside The United States, Cue Health has CE Mark in the European Union, Health Canada Provisional Approval, and Regulatory Approval from. obtain India Central organization for the standard control of pharmaceuticals. 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 all other statements about matters that are not historical facts, may constitute “forward-looking statements”. The words, without limitation, “anticipate”, “believe”, “continue”, “might”, “estimate”, “expect”, “intend”, “may”, “plan”, “potentially”, “predict”, “Project,” “should,” “goal,” “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 vary due to various important factors including those set out in the “Risk Factors” section of the Form 10-Q dated November 10, 2021 Filed by Cue with the SEC. All forward-looking statements in this press release are based on the current expectations of the Cue management team and speak only as of the date of this press release, and Cue expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
The Cue COVID-19 Home and Over-the-Counter (OTC) Test and the Cue COVID-19 Test (Professional) have not been approved or cleared by the FDA; but have been approved by the FDA under an Emergency Use Authorization (EUA). These products are only approved for the detection of SARS-CoV-2 nucleic acids, not for other viruses or pathogens. The emergency use of these products is only permissible for the duration of the declaration that circumstances exist that would require the approval of the emergency use of in-vitro diagnostics for the detection and / or diagnosis of COVID-19 in accordance with Section 564 (b) (1) of the federal government justify Food, Drug and Cosmetic Act, 21 USC Section 360bbb-3 (b) (1) unless the declaration is terminated or the authorization is withdrawn earlier.
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SOURCE Cue Health Inc.
