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San Diego, September 1, 2022 /PRNewswire/ — Cue Health (“Cue”) (Nasdaq: HLTH) announced today one more time Submission to the US Food and Drug Administration (FDA) for full clearance of the Cue® Flu Molecular Test for home and point-of-care (POC) use. There are currently no flu tests on the market for home use. FDA clearance of the Cue test will be the first at-home and POC molecular flu test to be evaluated by the FDA for safety and efficacy.
Clinical study results with the Cue Flu Molecular Test were excellent, showing 99% accuracy.1 Compared to FDA-refined molecular (PCR) laboratory tests for influenza A&B. The Cue Flu Molecular Test Cartridge uses a low nose tip and is compatible with the Cue Reader, which transmits test results digitally via Bluetooth to a mobile device within 25 minutes.
“This FDA approval for the Cue Flu Molecular Test is another important milestone on Cue’s path to pioneering a new diagnostic method in the home, corporate and healthcare settings,” he said. Ayub KatakChairman and CEO of Cue Health. “Early diagnosis and treatment can significantly improve health outcomes. Today, there are several FDA-approved antiviral treatments for the treatment of influenza, and thanks to our recent launch, we expect to quickly get these drugs into the hands of patients who need them. The Cue Care service.”
Cue’s molecular covid-19 test is currently under FDA approval for home and POC use under an Emergency Use Authorization (EUA). one more time Review with FDA. With over a quarter of a million installed Cue Readers shipped to date, cue’s COVID-19 test has been used by millions of Americans. Q is used by some of the nation’s leading healthcare institutions, including Johns Hopkins Medicine, Mayo Clinic, Memorial Hermann and Children’s Hospital of UPMC. Pittsburgh. Cue things like Major League Baseball, Google, the National Basketball Association, Bridgewaterwith others.
About Que’s health
Cue Health (Nasdaq: HLTH) is a healthcare technology company that provides individuals with easy access to health information and puts diagnostic data at the center of care. Cue Health enables people to monitor their health with real-time, actionable and connected health information, giving individuals and their healthcare providers easy access to quality laboratory testing anywhere, anytime, in a device that fits in the palm of their hand. Ku Health’s first-of-its-kind Covid-19 test is the first molecular test approved by the FDA for at-home and over-the-counter and physician-monitored use. outside AmericaCue Health has received the CE mark in the European Union, provisional order approval from Health Canada, regulatory approval from of India Central Drug Regulatory Organization, and PSAR license from Singapore Health Sciences Authority. Cue was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com.
Forward-looking statements
Any statements made in this press release about future expectations, plans and expectations and other matters that are not historical facts may constitute “forward-looking statements.” The words include, without limitation, “expect,” “believe,” “continue,” “may,” “estimate,” “expect,” “expect,” “may,” “plan,” “potential,” “forecast,” “project,” “should.” , “target”, “will”, “will” 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 forward-looking statements due to a number of important factors, including those discussed in the “Risk Factors” section of Cue’s Annual Report on Volume 10 of the list of expected future investigations. – For the completed year K December 31, 2021 And the quarterly report on Form 10-Q is completed in the quarter June 30, 2022 Filed with the SEC August 10, 2022. 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 disclaims any obligation to update any forward-looking statement as a result of new information. , future events or otherwise.
Cue’s COVID-19 tests are not FDA cleared or approved. But they are approved by the FDA and Emergency Use Authorization (EEA). These products are only approved for nucleic acid isolation from SARS-CoV-2 and not for other viruses or pathogens. Emergency use of these products is authorized under section 564(b)(1) of federal section 564(b)(1) only when conditions warrant emergency in vitro testing for detection and/or testing. Food, Drug, and Cosmetic Act, 21 USC § 360bbb-3(b)(1), unless the disclosure is terminated or the license is sooner revoked.
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1 A second FDA-cleared laboratory PCR test was used in the analysis of the controversy |
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Source: Cue Health Inc.
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