The US Food and Drug Administration (FDA) has granted Cue Health emergency use authorization (EUA) for its Cue Mpox Molecular Test to detect the mpox virus (formerly known as monkeypox).
Authorized to be used in professional point-of-care settings, the nucleic acid amplification test is intended to detect mpox virus DNA in lesion swab specimens from individuals suspected of mpox by their healthcare provider. According to the manufacturer, the test delivers results in 25 minutes and demonstrated high accuracy in trials, achieving 100% concordance with the Centers for Disease Control and Prevention’s mpox test on the clinical samples tested.
“At Cue, we are committed to developing innovative diagnostic solutions that empower both patients and healthcare providers with accurate and timely results,” says Ayub Khattak, CEO of Cue Health, in a press release. “The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform’s versatility.”
On Aug. 9, 2022, the Secretary of the Department of Health and Human Services declared a public health emergency or significant potential for one related to the mpox virus that could impact national security and the health of US citizens residing overseas.
Subsequently, on Sept. 7, 2022, the Secretary of Health and Human Service determined it was necessary to authorize emergency use of in vitro diagnostics for detecting and diagnosing infections caused by the mpox virus.
With symptoms ranging from fever and fatigue to severe skin eruptions and respiratory distress, early and accurate detection of mpox is crucial in controlling its spread and providing timely medical intervention, according to a press release by Cue Health.
“This EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases,” says the FDA in an email announcing the EUA.
