NOWDiagnostics will provide tropical disease tests in Africa
Effective December 8, 2020, NOWDiagnostics, Inc. has received Conformité Européene (CE) mark approval for its ADEXUSDx® COVID-19 ‘antibody fingerstick’ Test for use across 28 countries in the European Union (EU). The test first received CE mark approval for use in moderate/complex laboratory settings on July 28, 2020. The application for fingerstick use of the test was submitted November 2020 following completion of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver trial in the United States (U.S.).
C19 Development, LLC, a wholly owned subsidiary of NOWDiagnostics, will begin offering the ADEXUSDx® COVID-19 Test for fingerstick use in a variety of health care settings in the EU—from clinics to hospital emergency rooms, ...