This nucleic acid amplification test (NAAT) is run on a Cue Reader, can be performed at any CLIA-waived facility and delivers results in 25 minutes, the company says.
Further reading: Dissecting Limitations and Challenges of Mpox Testing
This EUA marks an important milestone for Cue Health, as it is the company’s first non-COVID test to receive FDA authorization, as well as its initial offering in the sexual health category for point-of-care diagnostics, Cue Health says.
The Cue Mpox Molecular Test requires using a Cue Sample Wand to collect a lesion sample or to dip into a viral transport medium (VTM) containing a specimen. The Cue Sample Wand is then inserted into the Cue Cartridge, which has been placed inside the Cue Reader. Results are delivered to a mobile device in 25 minutes. The test demonstrated high accuracy in trials, achieving 100% concordance with the CDC’s mpox test on the clinical samples tested, the company says.
“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. “The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform’s versatility.”
Mpox is a highly contagious and potentially severe viral infection that has recently emerged as a global health concern. 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.
Cue’s COVID-19 test was an earlier FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription. The company has since submitted an application to the FDA for an EUA for its Cue Flu + COVID-19 Molecular Test.
In addition, Cue’s standalone molecular tests for both flu and COVID-19 are under de novo review with the FDA for full clearance. Cue also expects to submit its RSV, strep throat, and chlamydia + gonorrhea multiplex tests to the FDA for review later this year.
Featured image: Cue Reader Photo: Cue