NOWDiagnostics of Springdale said it has been granted emergency use authorization for its COVID-19 antibody test by the United States Food and Drug Administration.
The company’s ADEXUSDx test had received Conformite Europeene mark approval for the test’s use in 28 European countries this past summer. NOWDiagnostics will offer the test in health care facilities that include pharmacies and emergency rooms.
The company said work is being done to make the test available for over-the-counter detection of COVID-19 antibodies.
The test uses a drop of blood, plasma or serum — typically acquired through a fingerstick — to detect the presence of the antibodies, and the company said results can be determined in 15 minutes. NOWDiagnostics requested EUA from the FDA in May 2020.
“The ADEXUSDx® COVID-19 Test is literally a lab at the tip of your finger, specifically designed to make diagnostic testing possible at home,” CEO Kevin Clark said “This EUA approval is the first step in making that a reality. We believe antibody testing is essential to America’s recovery from the COVID-19 pandemic, especially with the ongoing roll out of vaccines, and we’re proud to be responding to the urgent need for a reliable COVID-19 antibody test that targets the spike protein with our made-in-the-USA product.”
Sign up for Daily E-news
