Cue Health Files De Novo Application with FDA for Full Clearance of Cue® Flu Molecular Test
San Diego, September 1, 2022 /PRNewswire/ — Cue Health (“Cue”) (Nasdaq: HLTH) today announced de novo Submit to the U.S. Food and Drug Administration (FDA) for full approval of the Cue® Flu Molecular Test for home and point-of-care (POC) use. There are currently no commercially available home flu tests. FDA approval of Cue’s test marks the first public availability of his at-home POC molecular flu test, which has been fully reviewed by the FDA for safety and efficacy.
Positive clinical study results with the Cue Flu Molecular Test showed 99% accuracy1 Compared to FDA-approved molecular (PCR) laboratory tests for influenza A&B. The Cue Flu Molecular Test Cartridge uses a lower nasal swab and is compatible with the Cue Reader. The Cue Reader digitally communicates test results to your mobile device via Bluetooth in about 25 minutes.
“This FDA submission for our Cue Flu Molecular Test is another important milestone in Cue’s journey to pioneer new approaches to diagnostics in home, corporate and healthcare settings. Ayub Katak, Chairman and CEO of Cue Health. “Early detection and treatment can significantly improve health outcomes. There are multiple FDA-approved antiviral treatments for influenza available today, and thanks to their recent launches, patients in need of these drugs are on the rise.” We look forward to getting it into the hands of QCare services soon.”
Cue’s molecular COVID-19 test has been and remains FDA-approved for home and POC use under Emergency Use Authorization (EUA). de novo Subject to FDA review. With an installed base of over 250,000 Cue Readers shipped to date, Cue’s COVID-19 test is being used by millions of Americans. Cue is a member of the Johns Hopkins Medicine, Mayo Clinic, Memorial Hermann, UPMC Children’s Hospital of Pittsburgh. Cue has been recognized by major league baseball, Google, the National Basketball Association, bridgewateramong others.
About queue health
Cue Health (Nasdaq: HLTH) is a healthcare technology company that makes health information easily accessible to individuals and puts diagnostic information at the center of care. Cue Health empowers people to manage their health through real-time, actionable and connected health information, giving individuals and their healthcare providers easy access to lab-quality diagnostics anytime, anywhere, on a device that fits in the palm of your hand. will do so. His first COVID-19 test for Cue Health was the first FDA-cleared molecular diagnostic test that can be used at home or over the counter without a prescription or doctor’s supervision.outside usaCue Health is CE marked for the European Union, provisional order approval from Health Canada, and regulatory approvals. Indian PSAR approval from the Central Pharmaceutical Standards Authority, and Singapore’s Department of Health Sciences. Cue was founded in 2010 and is headquartered in San Diego. For more information, see: www.cuehealth.com.
Statements in this press release regarding future expectations, plans and prospects and other statements regarding matters that are not historical facts may constitute “forward-looking statements.” “predict”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “could”, “plan”, “possible” The words “possibly” and “predict” are not limited to these. The words “project,” “should,” “goal,” “will,” “will,” and similar expressions are intended to identify forward-looking statements; The description does not contain these or similar identifying terms. Actual results will be the result of a variety of important factors, including those related to anticipated future diagnostic testing menus and those discussed in the “Risk Factors” section of Cue’s Annual Report on Form 10. As such, they may differ materially from those indicated by such forward-looking statements. -K ending year December 31, 2021 Quarterly Report on Form 10-Q for the Closed Quarter June 30, 2022 filed with the SEC August 10, 2022The forward-looking statements contained in this press release are based on the current expectations of Cue’s management and speak only as of the date hereof, and Cue does not assume that they are the result of new information. expressly disclaims any obligation to update forward-looking statements regardless of , future events or otherwise.
Cue’s COVID-19 test has not been cleared or approved by the FDA. However, it is approved under the FDA and Emergency Use Authorization (EUA). These products are only approved for the detection of nucleic acids from SARS-CoV-2, not other viruses or pathogens. Emergency use of these products may warrant authorization for emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Federal Section 564(b)(1). Only allowed for the duration of the declaration. Food, Drug and Cosmetic Act, 21 USC § 360bbb-3(b)(1), unless declaration is terminated or authorization is revoked earlier.
1 Discordance analysis using a second FDA-approved laboratory PCR test
SOURCE QHealth Co., Ltd.