Cue Health has obtained de novo authorisation from the US Food and Drug Administration (FDA) for its Covid-19 at-home test, the Cue Covid-19 molecular test.
The new molecular nucleic acid amplification test has been developed for both point-of-care and home use.
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This test is used for the detection of the SARS-CoV-2 virus’s genetic material present in nasal swabs from adult patients exhibiting signs and symptoms associated with upper respiratory infection.
The Cue Covid-19 Test is claimed to be the first at-home over-the-counter test for Covid-19 to secure marketing authorisation via the De Novo pathway.
It is also the first home test to receive De Novo authorisation for any respiratory illness.
The US FDA Center for Devices and Radiological Health director Dr Jeff Shuren said: “Today’s authorisation is the first at-home Covid-19 test granted marketing authorisation outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home.”
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By GlobalDataThe easy-to-use and portable test kit includes a single-use Cue Covid-19 Test cartridge and Cue sample wand, as well as the Cue cartridge reader.
When the test is completed, results are displayed on the Cue Health app.
The reusable, battery-powered reader, also known as the Cue Health Monitoring System, is used with the Cue test cartridge and the wand to run diagnostic tests.
It sends the results directly to the app within 20 minutes.
Cue Health chairman and CEO Ayub Khattak said: “Our integrated test-to-treatment platform, coupled with the recent authorisation of our mpox test and several other molecular tests under FDA review or in clinical studies, helps enable faster and better-informed healthcare decisions while making care and treatment more convenient.”
