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Friday, September 20th, 2024

BARDA, NOWDiagnostics partnership proposes rapid, over-the-counter COVID-19 test

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A partnership between the Biomedical Advanced Research and Development Authority (BARDA) and NOWDiagnostics, Inc. will produce a rapid, point of care, in vitro diagnostic test for COVID-19 known as ADEXUSDx.

Based on the similarly named ADEXUSDx platform, the test proposes rapid detection of SARS-CoV-2 — the virus that causes COVID-19 — antibodies from drops of blood. The foundational platform is already commercialized for other non-COVID-19 tests, like a Food and Drug Administration (FDA) cleared professional use pregnancy test. The partners attest that it could provide results within 15 minutes.

This latest component of BARDA’s COVID-19 medical countermeasure portfolio is a rapid chromatographic immunoassay that also eliminates the need for many common testing materials through a fingerstick blood specimen applied directly from a lance site to the device. It would also eliminate any need for sample shipping and remote lab analysis, thereby reducing wait times further.

BARDA and NOWDiagnostics will work on the test together, with the end goal of earning emergency use authorization from the FDA. Collected data will provide info on the diagnoses of current infections, how the immune system responds to those infections, and help determine how SARS-CoV-2 spreads.