NOWDiagnostics Inc. of Springdale said Tuesday that it would offer its COVID-19 antibody tests to medical facilities in Europe.
The company said its subsidiary, C19 Development LLC, will offer its ADEXUSDx test facilities ranging from clinics to hospital emergency rooms. The company said it received Conformite Europeene mark approval for the test's use in 28 European countries.
A spokeswoman said the CE mark was equivalent to an Emergency Use Authorization from the U.S. Food and Drug Administration, for which the company has a pending application. She said clinical trials of the antibody tests would be done in the United States after FDA approval is obtained.
The company said its test takes a drop of blood to detect antibodies produced from exposure to the virus that causes COVID-19 and can deliver the results in 15 minutes. NOWDiagnostics said its test has produced 95.6% true positive results and 98.5% true negative results in trials.
"The ADEXUSDx COVID-19 Test is literally a lab at the tip of your finger, specifically designed to make diagnostic testing possible anywhere," company CEO Kevin Clark said. "While this CE mark permits our test to be used in laboratory settings, we expect that after completing clinical trials and obtaining further regulatory approvals, our ADEXUSDx COVID-19 Test will be available to everyone."