Cue’s molecular COVID-19 self-test provides laboratory-quality results in 20 minutes
SAN DIEGO, March 16, 2022 / PRNewswire / – Cue Health (“Cue”) (Nasdaq: HLTH), the health technology company behind most accurate at home COVID-19 test* in the US announced today that its COVID-19 molecular test is now available to individual consumers in Canada. The Cue Health Monitoring System (Reader) and Cue’s molecular COVID-19 test for the home can be accessed via Cue’s e-commerce site and in-app shop. Canadian consumers can also sign up for the Cue + Foundation membership, which gives users unlimited access to Cue’s supervised COVID-19 virtual proctor test in English and French for travel, work or school; ten (10) COVID-19 tests are included in each membership, as well as ongoing discounts on Cue products.
Cue has received temporary order approval from Health Canada to sell and distribute its COVID-19 test for both professional use in the nursing home and for consumer self-testing. The Cues test uses molecular nucleic acid amplification technology (NAAT), which delivers laboratory-quality results directly to connected mobile devices in 20 minutes. The test can detect all known COVID-19 variants and can be used on adults and children (aged 2 years and over), with or without symptoms. The monitored test meets the current entry requirements for COVID-19 tests for international travel in many countries around the world, including Canada and the United States, and the results are also often accepted by employers, schools and sports and entertainment venues.
“Following the successful launch of our smart home lab platform in the United States, we are pleased to now offer Canadian consumers access to our molecular COVID-19 self-test that combines accuracy, speed and reliability,” he said. Ayub Khattak, co-founder and CEO of Cue Health. “Canadians now want a more convenient molecular testing solution that gives them accurate results when they want peace of mind or to protect their loved ones when traveling, returning to work, or visiting entertainment and sports venues.”
Last year, Cue announced a partnership with Air Canada to give U.S.-based passengers access to Cue’s molecular COVID-19 test for their travel needs. Cue also provides tests to other world-class organizations such as Johns Hopkins Medicine, Mayo Clinic, Google, the National Basketball Association (NBA) and Major League Baseball (MLB) among many others. Looking ahead, Cue is working on new diagnostic tests – including for other respiratory diseases, sexually transmitted diseases, women’s and men’s health, cardiometabolic health and more – all of which will be compatible with the connected Cue Reader.
* Based on clinical study results submitted to the FDA for other EUA molecular home tests.
About Cue Health
Cue Health (Nasdaq: HLTH) is a healthcare technology company that makes it easy for individuals to access healthcare information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, action-friendly and connected healthcare information, giving individuals and their healthcare providers easy access to laboratory-quality diagnostics anywhere, anytime in the palm of your hand. Cue Health’s first of its kind COVID-19 test was the first FDA-authorized molecular diagnostic test for home and over-the-counter use without a prescription and medical supervision. Outside The United StatesCue Health has received the CE mark in the European Union, temporary order approval from Health Canada, regulatory approval from India Central Drugs Standard Control Organization and PSAR Authorization from Singapore The National Board of Health Sciences. Cue was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com.
Statements in this press release regarding future expectations, plans and prospects, as well as 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”, “can”, “plan”, “potentially”, “predict”, ” project “,” should “,” goal “,” will “,” would “and similar terms 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 stated by such forward-looking statements due to various important factors, including those related to the expected future diagnostic test menu and the factors discussed in the “Risk Factors” section of Form 10- Q dated. November 10, 2021 filed by Cue to 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 from the date hereof, and Cue specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or other things.
This product is approved for sale or import in Canada pursuant to section 5 of the Interim Executive Order on the import and sale of medical equipment for use in connection with COVID-19, issued by the Minister of Health d. March 18, 2020 and the subsequent interim executive order no. 2 regarding March 1, 2021.
IN The United States, these products have not been approved by the FDA or approved; but has been approved by the FDA under an Emergency Use Authorization (EUA). These products are only approved for the detection of nucleic acid from SARS-CoV-2, not for other viruses or pathogens. Emergency use of these products is approved only during the declaration that circumstances exist that justify the approval of emergency use of in vitro diagnostics for the detection and / or diagnosis of COVID-19 in accordance with § 564 (b) (1) of Federal Food, Drug and Cosmetic Act, 21 USC § 360bbb-3 (b) (1), unless the declaration is terminated or approval revoked more expeditiously.
SOURCE Cue Health Inc.