SPRINGDALE, Ark. (KNWA/KFTA) — A Springdale-based testing company announced on Monday that its COVID-19 antibody test has received the Conformité Européene (CE) mark approval for use in “moderate/complex laboratory settings” across 28 countries in the European Union (EU).
NOWDiagnostics, Inc. says its subsidiary, C19 Development, LLC., will begin offering the ADEXUSDx® COVID-19 Test for use in a variety of health care settings in the EU—from clinics to hospital emergency rooms, while launching clinical trials of the test for use at point-of-care and over-the-counter.
The company says the test provides accurate and reliable results in 15 minutes with no buffers, reagents, or additional equipment necessary.
NOWDiagnostics says it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the test on May 29, 2020. The application is still pending.
The tests are developed and manufactured at the company’s Springdale facility with materials “sourced from American suppliers.”
The Centers for Disease Control and Prevention (CDC) and others are analyzing data from antibody tests to estimate the number of people who have been infected with COVID-19 in the U.S., to learn more about how the body’s immune system responds to the virus, and to explore how the virus spreads. This information will also be critical for the development of a vaccine. We believe that the features of the self-contained ADEXUSDx® COVID-19 Test, from its simplicity to its portability, make it uniquely suited for large-scale and remote testing situations, as well as under resourced areas lacking access to traditional health care laboratories and facilities, like those encountered by those fighting on the frontline, in particular, healthcare employees, police, fire, emergency medical services and military personnel.NOWDiagnostics, Inc.