The Food and Drug Administration has authorized the first at-home, over-the-counter test for COVID-19 using a traditional premarket review pathway rather than emergency use authorization, the agency reported Tuesday.
The Cue COVID-19 Molecular Test, made by Cue Health Inc., is also the first ever at-home test for any respiratory illness approved using the traditional pathway, the FDA said. In an FDA-reviewed study, it correctly identified 99% of negative and 93% of positive samples in people with symptoms of upper respiratory infection.
The authorization is part of the agency’s broader effort to expand patient access to testing, according to Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
“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,” he said.
During the pandemic, beyond general convenience, the advent of at-home COVID-19 tests was a boon to consumers, allowing them to diagnose respiratory symptoms while remaining distanced during pandemic lockdowns. At the same time, the eventual popularity of these home tests likely thwarted health officials’ efforts to accurately track COVID-19 case counts and positivity rates. This data was a crucial tool for informing people, including long-term care staff and residents, of community risk levels.
In the fall of 2020, HHS and the Department of Defense delivered millions of rapid, point-of-care antigen tests to nursing homes and assisted living communities. It was an unprecedented effort to ensure consistent screening of staff and residents as the long-term care industry fought to reduce the spread of COVID-19.
Following that action, the first COVID-19 molecular diagnostic test was authorized for self-testing at home by consumers. That test required a prescription. Subsequent tests that did not require a doctor’s OK received approval shortly after.
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