FDA grants marketing authorization for Cue OTC, at-home COVID-19 test

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The at-home test correctly identified 98.7% of negative and 92.9% of positive samples for individuals with signs and symptoms of upper respiratory infection, according to a study reviewed by the FDA.

FDA grants marketing authorization for Cue OTC, at-home COVID-19 test | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

FDA grants marketing authorization for Cue OTC, at-home COVID-19 test | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

The Cue COVID-19 Molecular over the counter (OTC), at-home test has been granted marketing authorization by the FDA. According to a press release from the agency, the Cue COVID-19 test is the first OTC, at-home test to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.1

The Cue COVID-19 test is intended for adults to self-swab or children 2 years or older, to be swabbed by an adult.2 The product, a molecular nucleic acid amplification test (NAAT), is intended to detect genetic material from the SARS-CoV-2 virus that is present in nasal swabs. A study reviewed by the FDA demonstrated that the at-home test correctly identified 98.7% of negative and 92.9% of positive samples for individuals with signs and symptoms of upper respiratory infection. The test consists of a single-use Cue COVID-19 test cartridge, single-use Cue nasal swab, and a Cue Cartridge Reader that is sold separately. The Cue Cartridge Reader can communicate results to the Cue Health app, which displays results when the test is complete (approximately 20 minutes).1

“Today’s authorization is the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”

The FDA notes, as with all rapid tests, risk of false positive and false negative results is present. Those that test positive for SARS-CoV-2 should take appropriate precautions and seek follow-up care, as additional testing may be necessary. If a result is negative, the FDA states it should be confirmed by a lab-based molecular test if necessary for patient management.1

If individuals test negative but continue to experience symptoms of fever, cough and/or shortness of breath, they may still have SARS-CoV-2 or another respiratory infection. Follow-up care from a health care provider should be sought out in these individuals.1 According to Cue, the test does not differentiate between SARS-CoV and SARS-CoV-2. Positive results do not rule out a bacterial infection or coinfection with other viruses, and the agent detected may not be the definite cause of disease.2

References:

1. FDA permits marketing of first COVID-19 at-home test using traditional premarket review process. FDA. June 6, 2023. Accessed June 7, 2023. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process

2. The Cue COVID-19 test for home and over the counter (OTC) use instructions for use. Cue Health. Accessed June 7, 2023. https://www.fda.gov/media/146470/download

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