NEW YORK — NowDiagnostics said on Monday that it is working with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop a test for SARS-CoV-2 antibodies that can be used in many healthcare settings, including clinics, hospital emergency rooms, and at home.
The COVID-19 rapid antibody test leverages NowDiagnostics' self-contained AdexusDx COVID-19 platform.
BARDA is providing technical support to assist NowDx with an application for Emergency Use Authorization from the US Food and Drug Administration for point-of-care and over-the-counter uses. The agency has awarded NowDx $695,500 for the test's development.
NowDx filed for FDA EUA in May for use of the test in moderate complexity settings.
The platform requires no reagents, buffers, equipment, or refrigeration, and operates from a fingerstick of capillary blood, venous whole blood, serum, or plasma, NowDx said.
The Springdale, Arkansas-based firm added that the test delivers lab-quality results in 15 minutes by detecting the presence of SARS-CoV-2 antibodies in people with previous virus exposure.
In July, the diagnostics firm said it received CE marking for the AdexusDx COVID-19 test.
To date, the FDA has granted no EUAs for SARS-CoV-2 tests that can be completed from start to finish in the home.