The nucleic acid amplification test is now cleared for use in professional point-of-care settings in the US to detect mpox virus and deliver results in 25 minutes
Cue Mpox Molecular Test is a nucleic acid amplification test that can deliver results in 25 minutes. (Credit: Cue Health Inc.)
Cue Health has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for Cue Mpox Molecular Test, its molecular test to detect the mpox virus (monkeypox).
The California-based healthcare technology company designed the nucleic acid amplification test (NAAT) for fast and accurate testing of patients with results in around 25 minutes.
Cue Health said that the test can be run on a Cue Reader, and can be performed at any CLIA-waived facility under professional point-of-care settings.
Designed with ease of use in mind, the Cue Mpox Molecular Test needs only a Cue Sample Wand to collect a lesion sample or for dipping into a viral transport medium (VTM) that contains a specimen.
The Cue Sample Wand is then put into the Cue Cartridge, which has been already placed inside the Cue Reader. The results are sent to the patient’s mobile device in 25 minutes, according to the healthcare technology firm.
The company said that the test achieved 100% concordance with the CDC’s mpox test, showing high accuracy in trials on the clinical samples tested.
Cue Health CEO Ayub Khattak said: “At Cue, we are committed to developing innovative diagnostic solutions that empower both patients and healthcare providers with accurate and timely results.
“The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform’s versatility.”
The EUA for Cue Mpox Molecular Test is said to be significant for the company as it is the first non-COVID test to get FDA authorisation. Apart from that, the test is the company’s initial offering in the sexual health category for point-of-care diagnostics.
The firm’s COVID-19 test was the first FDA-authorised molecular diagnostic test that can be used at-home and over-the-counter use without a prescription.
Additionally, the healthcare technology firm’s molecular tests for both flu and COVID-19 are under de novo review with the US regulator for full clearance.