NOWDiagnostics has received Conformité Européene (CE) Mark approval for its ADEXUSDx COVID-19 ‘antibody fingerstick’ Test, a rapid serology, self-contained assay.
The test can now be used in 28 countries in the EU.
NOWDiagnostics subsidiary, C19 Development, will start offering the test for fingerstick use in various healthcare settings in the EU and commence its clinical trials for use over the counter.
In July, the test received CE mark approval for use in moderate / complex laboratory settings.
NOWDiagnostics applied for fingerstick use of the test after completing a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver trial in the US.
By measuring the presence of SARS-CoV-2 antibodies, the ADEXUSDx COVID-19 Test provides precise and reliable results in 15 minutes and eliminates the need for buffers, reagents, or additional equipment.
It needs 40μL of fingerstick or venous whole blood, plasma, or serum to check for the presence of the antibodies.
The test had shown a high level of analytical performance with a sensitivity of 95.6% and a specificity of 98.5%.
NOWDiagnostics CEO Kevin Clark said: “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 US, pending regulatory approval.”
Developed and manufactured at NOWDiagnostics facility in Springdale, Arkansas, the test will get materials sourced from US suppliers.
In addition, NOWDiagnostics submitted an application to the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) of the test. It is now under review, the company noted.