Cue Health’s COVID-19 Test Receives CE Mark

Cue Health has received CE mark certification for its Cue COVID-19 Test, a rapid molecular point-of-care test.

The nucleic acid amplification test (NAAT) runs on the company’s Cue Health Monitoring System and displays test results on a connected mobile smart device app in approximately 20 minutes.

The test consists of a single-use test cartridge, a lower nasal swab and a reusable, battery-powered cartridge reader that delivers the results to the mobile app. In addition to its recent European clearance, the company previously received Emergency Use Authorization from the FDA for the product.