Sam Brusco, Associate Editor03.21.23
Cue Health has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its molecular test to detect the mpox (monkeypox) virus.
The nucleic acid amplification test (NAAT) runs on a Cue Reader, can be performed at any CLIA-waved facility, and generates results in 25 minutes. This EUA marks the company’s first non-COVID test to earn FDA authorization and is its initial offering in the sexual health category of point-of-care diagnostics.
The Cue Mpox molecular test requires a Cue Sample Wand to collect a lesion sample or to dip into a viral transport medium (VTM) containing a specimen. The sample wand is then inserted into the Cue cartridge placed inside the Cue reader.
The test showed high accuracy in trials, achieving 100% concordance with the CDC’s mpox test on 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," Ayub Khattak, CEO of Cue Health told the press. "The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform's versatility."
Cue expects to submit its RSV, strep throat, and chlamydia + gonorrhea multiplex tests to the FDA for review later this year.
The nucleic acid amplification test (NAAT) runs on a Cue Reader, can be performed at any CLIA-waved facility, and generates results in 25 minutes. This EUA marks the company’s first non-COVID test to earn FDA authorization and is its initial offering in the sexual health category of point-of-care diagnostics.
The Cue Mpox molecular test requires a Cue Sample Wand to collect a lesion sample or to dip into a viral transport medium (VTM) containing a specimen. The sample wand is then inserted into the Cue cartridge placed inside the Cue reader.
The test showed high accuracy in trials, achieving 100% concordance with the CDC’s mpox test on 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," Ayub Khattak, CEO of Cue Health told the press. "The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform's versatility."
Cue expects to submit its RSV, strep throat, and chlamydia + gonorrhea multiplex tests to the FDA for review later this year.