The Cue Covid-19 molecular test provides results in approximately 20 minutes. Credit: Tye Thomas G. from Pixabay.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.”