FDA Authorizes First At-Home Molecular COVID-19 Diagnostic Test

March 11, 2021 - FDA recently issued an emergency use authorization for an at-home and over-the-counter (OTC) COVID-19 diagnostic test.

The Cue COVID-19 Test for Home and OTC Use test is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils.

The test is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens collected with the Cue Sample Wand, FDA explained. It is approved for use in adults via self-swabbing and children two years of age and older when swabbed by an adult. 

Notably, this is the first FDA-authorized molecular test for at-home use without a prescription. 

“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement. 

“The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Woodcock continued. 

The authorized test includes the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader, which is used by the Cue Health Monitoring System, and the Cue Health Mobile Application, which can be downloaded onto smartphone devices.

The reusable and battery-operated Cue Cartridge Reader runs on the Cue Test Cartridge and communicates results directly to the Cue Health App in nearly 20 minutes.

The mobile application requires individuals to create an account and will be updated in the future to include the ability to report test results as appropriate to public health authorities to monitor disease prevalence, FDA stated. 

“For the first time, consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of COVID-19 testing,” Ayub Khattak, co-founder and CEO of Cue Health, said in a press release following the authorization. 

“With this FDA authorization, 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,” Khattak continued. 

In prospective studies comparing the Cue Health OTC Test to a highly sensitive PCR laboratory-based test authorized for emergency use by the FDA, researchers found a 97.4 percent agreement for positive cases and a 99.1 percent agreement for negative cases. 

The company expects to produce over 100,000 tests per day by this summer. 

FDA has authorized more than 330 tests and collection kits for a variety of uses, users, and locations to provide a wide range of test options. 

At the end of December, FDA issued an emergency use authorization for the first OTC, at-home COVID-19 diagnostic test to be used in individuals two years of age and older.

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test. This means that it runs a liquid sample along a surface with reactive molecules to detect if SARS-CoV-2 is present in an individual, FDA said in the December announcement. 

In previous studies, the test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In those without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

Days later, FDA issued an emergency use authorization for Abbott’s COVID-19 antigen test, the BinaxNOW COVID-19 Ag Card Home Test. It is intended for use in patients 15 years of age and older who are suspected of COVID-19 and who are in the first seven days of symptom onset.

The test can only be used with prescription.