BARDA is collaborating with NOWDiagnostics, Inc. to develop the ADEXUSDx® COVID-19 Test, a rapid, in vitro, diagnostic test for use in both point-of-care (POC) settings and OTC for at home, using the NOWDiagnostics’ ADEXUSDx® platform, for rapid detection of human antibodies against SARS-CoV-2 from a drop of blood.
BARDA and NOWDiagnostics, Inc. will work together on the development of this rapid, accurate, self-contained, POC and OTC test for the detection of antibodies against SARS-CoV-2 in blood and to achieve Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test leverages the ADEXUSDx® device platform, already commercialized for other tests, including an FDA-cleared professional use pregnancy test which is also CE marked for self-testing. Results would be visually read by users within 15 minutes.
The test is a rapid chromatographic immunoassay that utilizes a fingerstick blood specimen that is applied directly from the lance site to the test device, eliminating the need of common test materials that may be in short supply due to the global impact of the COVID-19 pandemic. The test also eliminates the need of shipping the sample and of remote laboratory analysis.
By assessing the presence of SARS-CoV-2 antibodies in patients who have had symptoms characteristic of COVID-19 infection, data from the ADEXUSDx® COVID-19 test will provide important information for the diagnoses of current infections, and will aid in the determination of how SARS-CoV-2 spreads and how the immune system responds to the infection.
About NOWDiagnostics, Inc.
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
NOWDiagnostics, Inc., based in Springdale, Arkansas, is a leader in innovative diagnostics testing. Its proprietary ADEXUSDx® platform features a lab at your fingertip, using a single drop of blood to test for a variety of common conditions, illnesses, and diseases, with results in a matter of minutes. By eliminating the need to send tests to off-site laboratories, NOWDiagnostics products have the potential to decrease the waiting period to determine test results from days to minutes. For more information about NOWDiagnostics, visit https://www.nowdx.com/. For more information about the ADEXUSDx® COVID-19 Test, including its intended use, features, benefits and limitations, and directions for use, visit https://www.c19development.com/.