Cue Health has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its at-home and over the counter (OTC) Covid-19 molecular diagnostic test.
The lower nasal swab is used by the Cue Covid-19 at-home and OTC test (Cue OTC Test) to deliver results within 20 minutes. The mobile smart device can be used by the user to check the results.
The Cue OTC test is designated for use by symptomatic and asymptomatic individuals, adults and children aged two and older with adult assistance, said the company.
Designed to run on the rechargeable Cue Cartridge Reader, the sensitive and specific nucleic acid amplification test (NAAT) will help identify the RNA of SARS-CoV-2, the virus responsible for the Covid-19 disease.
Each Cue OTC Test Cartridge Pack consists of the single-use and self-contained Cue Test Cartridge and the Cue Sample Wand swab for minimally invasive sample collection.
In June last year, the Cue Covid-19 test secured FDA EUA status for use in the clinical and point-of-care settings.
At present, the tests are supplied to the K-12 schools, essential businesses, nursing homes and other congregate-care facilities, hospitals, physicians’ offices and dental clinics in the US.
The Cue Health Monitoring System is a portable, compact and connected diagnostic platform designed to work with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App for the transformation of test samples into precise digital results.
Cue Health co-founder and CEO Ayub Khattak said: “With this FDA authorisation, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem.
“Our guiding principle has been to revolutionize diagnostics to transform health outcomes and we are so proud to lead this transformative paradigm shift in the U.S. healthcare system.”
