NEW YORK – Cue Health announced on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its molecular monkeypox test.
The nucleic acid amplification test returns results in 25 minutes and is authorized for use in CLIA-waived settings, the company said in a statement. To run the assay, users collect a lesion sample via the Cue Sample Wand, insert the wand into the Cue Cartridge, and place the cartridge into the Cue Reader, with results returned to a mobile device.
The test achieved 100 percent concordance with the US Centers for Disease Control and Prevention's monkeypox test on the clinical samples tested, Cue noted.
The Cue Mpox Molecular Test is Cue Health's first non-COVID-19 test to receive FDA authorization and the first point-of-care test in its sexual health category. The San Diego-based company has submitted its multiplex influenza and COVID-19 test to the FDA for EUA, and both its COVID-19 and influenza standalone tests are under de novo review with the agency, Cue noted.