Tuesday, March 21, 2023
Cue Health announced it has received Emergency Use Authorisation (EUA) from the United States Food and Drug Administration (FDA) for its molecular test to detect the mpox virus (formerly known as monkeypox). 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, significantly expanding access to fast and accurate testing for patients.
The FDA Emergency Use Authorisation (EUA) for Mpox Molecular Test provides a great tool for clinicians and patients and demonstrates platform's versatility. Cue's COVID-19 test is the first FDA-authorised molecular diagnostic test for at-home and over-the-counter use without a prescription.
The test simply 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.
