NOWDiagnostics has received approval for its antibody fingerstick test in 28 countries in the European Union (EU).
The Springdale-based company received the Conformité Européene (CE) mark approval for the ADEXUSDx® COVID-19 test, which was effective Dec. 8. NOWDignostics previously received a moderate/complex laboratory setting CE mark approval, and in November 2020, the company applied for the fingerstick use.
“The ADEXUSDx® COVID-19 Test is literally a lab at the tip of your finger, specifically designed to make diagnostic testing possible anywhere. We are thrilled that the compelling performance data from our CLIA waiver clinical trial have resulted in expanded regulatory approval of the test as a fingerstick assay. We look forward to making this easy-to-use fingerstick test available for use in Europe first, then at home in the U.S., pending regulatory approval NOWDiagnostics, Inc. CEO Kevin Clark said in a statement.
Following the approval, NOWDiagnostics’ C19 Development will begin offering the fingerstick test in multiple EU health care settings, including clinics, emergency rooms and more.
The company is also launching clinical trial for the test to be used as an over-the-counter tool.
This approval comes after NOWDiagnostics requested expanded Emergency Use Authorization for the test from the U.S. Food and Drug Administration (FDA). The expanded EUA would allow the company to expand the point-of-care tests beyond laboratory settings into health care settings.
In a previous news release, NOWDiagnostics’ wholly owned subsidiary C19 Development announced that it would begin offering the ADEXUSDx® COVID-19 Test for use in CLIA-waived facilities in the United States.