Cue Receives CE Mark for Its Molecular Point-of-Care COVID-19 Test
Highly Sensitive and Specific, Lower Nasal Swab Test Offering Ease-of-Use and Accurate Diagnosis
San Diego, CA (February 23, 2021) - Cue Health Inc. (Cue), a healthcare technology company, today announced its molecular point-of-care COVID-19 Test has received the CE mark, clearing it for sale and distribution in the European Union (EU).
The Cue COVID-19 Test is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the Cue Health Monitoring System, displaying test results directly on a connected mobile smart device in about 20 minutes via the Cue Health App. The Cue COVID-19 Test consists of the Cue Test Cartridge, which is a single-use, self-contained, high-sensitivity molecular assay, and the Cue Sample Wand, a lower nasal swab for minimally invasive sample collection. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App. Altogether, the Cue COVID-19 Test and the Cue Health Monitoring System is a portable and connected diagnostic platform, compact enough to fit in the palm of your hand, that provides fast and accurate lab-quality molecular testing at point-of-care.
“We are pleased to have received the CE Mark for Cue’s COVID-19 Test in the European Union,” said Clint Sever, Chief Product Officer of Cue. “The Cue COVID-19 Test brings lab-quality performance to the point-of-care, enabling fast clinical decisions for patient triage and care. Accurate and rapid diagnosis is critical for infection control as businesses and communities aim to re-open and remain open by practicing safety protocols and regular testing, even with the rollout of the vaccine underway.”
Cue’s COVID-19 Tests are currently being used in the U.S. in point-of-care settings, such as K-12 schools, essential businesses, nursing homes and other congregate-care facilities, hospitals, physicians’ offices, dental clinics, and more. The test is also being utilized via a program led by the U.S. Department of Defense (DOD) and the U.S. Department of Health and Human Services (HHS) across several U.S. states.
About the Cue Health Monitoring System
The Cue Health Monitoring System is a portable, compact, connected diagnostic platform that provides the power of lab-quality molecular testing at point-of-care, when and where it is needed the most. The Cue Health Monitoring system works with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App to convert test samples into accurate digital results. The Cue COVID-19 Test Cartridge is a single-use, self-contained, high-sensitivity molecular assay. The Cue Sample Wand is a lower nasal swab supplied with the Cue Test Cartridge. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes via a mobile smart device. The Cue Health App on the user’s mobile smart device is the interface for test information, instructions, and display of the test results.
About Cue Health
Cue Health Inc. (“Cue”) is an ISO 13485-certified company focused on developing and manufacturing professional and consumer medical diagnostic products that can be used in clinical or at-home settings. Cue’s mission is to create tools that empower healthcare providers and consumers by increasing their access to actionable health data. Cue’s first product, the Cue Health Monitoring System with the Cue COVID-19 Test Cartridge, is a platform that provides diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem.
These products have not been FDA cleared or approved; but have been authorized by FDA under an 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.
February 23, 2021
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