July 31, 2020 -- The FDA widened the landscape for COVID-19 testing that can be handled at home, as long as companies follow new rules released Wednesday.
The agency posted a new template for commercial developers to submit an emergency use authorization request, which will allow them to make fast, cheap, accessible tests that people can use at home, in offices and in schools without a prescription.
The update is “intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test,” Stephen Hahn, MD, the commission of the FDA, said in the news release. Hahn called the tests a “game changer” in the fight against the coronavirus.
“We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available,” he said.
Until now, the FDA hasn’t allowed companies to sell at-home tests, according to USA Today, and lab tests have often been restricted to those who have COVID-19 symptoms. Facing a high demand for testing, commercial labs across the country are addressing a backlog that often takes days to return results to patients.
Rapid tests are available but often expensive, the newspaper reported. Some labs charge $150 or more for these tests, and they often aren’t covered by health insurance.
The new FDA template includes recommendations for validating samples, as well as guidelines for validating tests that will be available over-the-counter to consumers. The FDA also included recommendations for the sensitivity and specificity of these rapid tests so people can get accurate results at home.
“While the recommended sensitivity for these non-lab tests is lower than lab-based tests, the tremendous benefits of broader access to simple and fast testing options generally outweighs this risk,” according to the statement.