NEW YORK — NowDiagnostics said on Tuesday that it has received CE marking for its AdexusDx COVID-19 antibody test for SARS-CoV-2.
The test is designed to detect immunoglobulin G, M, and A antibodies against SARS-CoV-2 using a single drop of whole blood, plasma, or serum, according to the Springdale, Arkansas-based company. Results are provided within 15 minutes.
NowDx said that it is planning clinical trials of the test for point-of-care use and over-the-counter sale. The company submitted the test to the US Food and Drug Administration for Emergency Use Authorization in May and is awaiting a decision, it 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," NowDx CEO Kevin Clark said in a statement.