NOWDiagnostics has filed for an expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 antibody test.
This expanded authorization is for NOWDiagnostics’ ADEXUSDx® COVID-19 Test, which is designed for point-of-care use. According to the company, there is a prospective clinical trial of the antibody test that “demonstrated a high level of analytical performance using the test’s revolutionary “touch-to-test” technology.”
This EUA filing would enable NOWDiagnostics to expand the usage of the test beyond its original use in moderate complex laboratory settings. The “rapid serology, self-contained assay” has been developed by NOWDiagnostics to be used in a range of health care settings, including emergency rooms and clinics, as well as for in-home use.
This test measures the presence of antibodies against the SARS-CoV2 virus and provides “lab quality results) within 15 minutes. The test requires a drop of blood, which can be drawn from a fingerstick, or from venous whole blood, serum or plasma.
According to a news release, NOWDiagnostics’ wholly owned subsidiary C19 Development will begin offering the ADEXUSDx® COVID-19 Testfor use in CLIA-waived facilities.
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