Cue Health (Cue), a healthcare technology company, 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.