The US Food and Drug Administration (FDA) has issued its first ever Emergency Use Authorization (EUA) for a Covid-19 molecular diagnostic test to be purchased over the counter (OTC).
Cue Health’s Cue Covid-19 Test for Home and Over the Counter Use was authorised by the FDA for point-of-care testing last June, but is now approved to be purchased directly to use at home without a prescription.
The nucleic acid amplification test (NAAT) diagnoses the disease by analysing a lower nasal swab sample taken using the single-use Cue Sample Wand, which is run through the reusable Cue Cartridge Reader.
The test is authorised for use in both symptomatic and asymptomatic adults, as well as in children aged two or over with adult assistance.
The results are delivered to the user’s mobile phone via the Cue Health App within about 20 minutes.
Consumers who wish to use the system will need to create an account to do so, which in the future will be updated to include the capability to report test results as appropriate to public health authorities to monitor disease prevalence.
In prospective studies of the Cue OTC Test, the results were 97.4% in agreement for positive cases and 99.1% in agreement for negative cases compared to results from an EUA PCR laboratory-based test.
Cue co-founder and CEO Ayub Khattak said: “For the first time, consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of COVID-19 testing.
“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 revolutionise diagnostics to transform health outcomes and we are so proud to lead this transformative paradigm shift in the US healthcare system.”
Cue’s test is also being distributed across several US states via a $481m program led by the US Department of Defense (DOD) and the US Department of Health and Human Services (HHS).
The tests are currently being used in numerous public facilities throughout the US, including schools, essential businesses, care facilities, hospitals, physicians’ offices and dentists.
The FDA has authorised more than 330 tests and collection kits for a variety of uses, users and locations to provide a wide array of test options during the pandemic.
The regulator is currently prioritising the review and authorisation of EUA requests to account for numerous factors, such as the public health need of a product plus its availability or capacity, rather than just one.
The US Center for Devices and Radiological Health (CDRH) is increasingly declining to review EUA requests or terminating pending EUAs, on the basis that the EUA is not high enough priority or that there are already adequate alternatives on the market.