Created by Australia-based Ellume, which signed a $30 million National Institutes of Health contract to develop the test, it can deliver results in only about twenty minutes and will cost roughly $30. It is designed for individuals ages two and up, including those who are asymptomatic.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as twenty minutes,” FDA Commissioner Dr. Stephen Hahn said in a news release.
“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
For Ellume’s test, patients are directed to collect a mid-turbinate nasal swab so that virus antigens can be detected. The product utilizes an analyzer that is connected with a software application on a smartphone to help users perform the test and interpret the results. It also allows results to be shared with a health-care provider.
The test has boasted a 96 percent accuracy rating in positive samples taken from symptomatic patients, and 100 percent of negative samples in those who exhibit symptoms. For individuals who are asymptomatic, the test correctly identified 91 percent of all positive samples and 96 percent of negative ones.
Ellume said that it will deliver twenty million home tests to the United States through June 2021.
Medical experts have long called for the authorization of such home tests to alleviate the nation’s testing crunch, which has placed much stress on labs and delayed results for both consumers and medical providers.
“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them. Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a release.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
Ethen Kim Lieser is a Minneapolis-based Science and Tech Editor who has held posts at Google, The Korea Herald, Lincoln Journal Star, AsianWeek, and Arirang TV. Follow or contact him on LinkedIn.