FDA issues emergency authorization for first at-home COVID-19 test

Nov. 18 (UPI) -- The U.S. Food and Drug Administration has issued an emergency authorization for the first rapid coronavirus test that can be administered at home.

The agency announced the authorization for the all-in-one test kit late Tuesday in response to a request by Kelly Lewis Brezoczky of Lucira Health, the California-based company that developed the test.

In a letter to Brezoczky, the FDA said the test meets the criteria for an emergency use authorization as there are no available alternatives and the product's benefits outweigh its known and potential risks.

The test has been authorized for use with samples collected from the nasal cavity of those age 14 years and older whose doctors suspect they have been infected with the coronavirus. Use in doctor's offices, hospitals, urgent care centers and emergency rooms has been approved for all ages.

While there have been other products approved for collecting samples at home, the Lucira product is the first to be fully self-administered and to provide results without a physician's assistance.

The company's website said the test is intended to cost under $50 and is designed to provide results within 30 minutes.

"Today's authorization for a complete at-home test is a significant step toward FDA's nationwide response to COVID-19," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

FDA Commissioner Stephen M. Hahn said the development of a COVID-19 test that can be administered outside a healthcare setting has been a major priority for the FDA, and now that there is one more people who suspect that they may have been infected with the virus can take immediate action to protect themselves and their community.

"We look forward to proactively working with test developers to support the availability of more at-home test options," he said.

The FDA approval was issued as the nation deals with a growing widespread outbreak. According to data collected by Johns Hopkins University, the United States has recorded more than 150,000 case a day in five of the last six days.

The United States has reported more than 11.3 million infections and nearly 250,000 deaths, making it by far the sickest country to the pandemic.