June 6, 2023 - FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process

Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 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. 

“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, M.D., J.D., 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 Cue COVID-19 Molecular Test consists of a single-use Cue COVID-19 test cartridge, a single-use Cue sample wand (nasal swab), and the Cue cartridge reader (sold separately). The test also uses the Cue Health app, which displays results when the test is complete. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the app in about 20 minutes. In a study reviewed by the FDA, this test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection.

As with all rapid tests, there is a risk of false positive and false negative results. Individuals who test positive for SARS-CoV-2 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be confirmed by a lab-based molecular test if necessary for patient management. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 or another respiratory infection and should seek follow up care with their healthcare provider.

Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted the marketing authorization to Cue Health Inc.

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