Month: December 2020

Self-Contained, Rapid ADEXUSDx® COVID-19 Antibody Fingerstick Test Receives CE Mark for Deployment Across European Union

SPRINGDALE, AR, December 17, 2020 – 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 …

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ADEXUSDx® COVID-19 Antibody Test Filed for Point of Care Emergency Use Authorization

SPRINGDALE, Ark., Dec. 10, 2020 /PRNewswire/ — NOWDiagnostics, Inc. announced today that it has filed for expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) of the ADEXUSDx® COVID-19 antibody test for point-of-care (POC)/CLIA waived testing. A prospective clinical trial of the ADEXUSDx® COVID-19 Antibody Test performed across three geographically diverse clinical sites demonstrated a …

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ADEXUSDx® COVID-19 Antibody Test Filed for Emergency Use Authorization Confirmed 100% Accurate with BEI Panel

SPRINGDALE, Ark., Dec. 7, 2020 /PRNewswire/ — NOWDiagnostics, Inc. announced today that study results for its ADEXUSDx® COVID-19 antibody test yielded encouraging test performance—providing a strong use case for the innovative diagnostic device, which was filed for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on May 29, 2020. The antibody test  delivered 100 percent sensitivity and …

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