Cue Health Becomes First Company to Receive FDA De Novo Authorization COVID-19 Home Use Test

Cue Health Inc HLTH became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.

The de novo is a device classification process that allows the FDA to classify new devices that are not equivalent to the existing Class I or II devices.

Originally made available to consumers without a prescription through a 2021 FDA Emergency Use Authorization (EUA), Cue's COVID-19 test delivers results in just 20 minutes to connected mobile smart devices. 

With a demonstrated overall accuracy of 98%, the test detects all known COVID-19 variants of concern and integrates into Cue Care, the company's test-to-treatment service.

The project has been funded in whole or in part with federal funds awarded by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, beginning in June 2018.

Last month, Cue Health submitted a De Novo to the FDA for full clearance of the Cue RSV Molecular Test for at-home and point-of-care use. 

There are currently no respiratory syncytial virus (RSV) tests for home use. Pending FDA clearance, Cue's test would provide the public, for the first time, an at-home molecular RSV test to use on people of all ages.

Price Action: HLTH shares are down 3.94% at $0.57 during the premarket session on the last check Wednesday.