NEW YORK ─ Cue Health said on Tuesday that it has received the CE mark for its molecular point-of-care COVID-19 test, clearing it for sale in the European Union and other regions that accept the designation.
The nucleic acid amplification test ─ compact enough to fit in the palm of a hand ─ consists of the single-use Cue Test Cartridge and the Cue Sample Wand, a lower nasal swab for sample collection. It runs on the Cue Health Monitoring System and displays test results on a connected mobile device in about 20 minutes via an app. A reusable, battery-operated reader and the cartridge communicate results directly to the health app, the firm said.
San Diego-based Cue added that US-based K-12 schools, essential businesses, hospitals, physicians' offices, dental clinics, nursing homes, and other congregate-care facilities are already using its COVID-19 test. It is also being used in several states under a program led by the US Department of Defense and the US Department of Health and Human Services.