SPRINGDALE, Ark., Dec. 10, 2020 /PRNewswire/ — NOWDiagnostics, Inc. announced today that it has filed for expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) of the ADEXUSDx® COVID-19 antibody test for point-of-care (POC)/CLIA waived testing. A prospective clinical trial of the ADEXUSDx® COVID-19 Antibody Test performed across three geographically diverse clinical sites demonstrated a high level of analytical performance using the test’s revolutionary “touch-to-test” technology.
This EUA filing is for the expanded use of the ADEXUSDx® COVID-19 antibody test, originally submitted for EUA use in moderate complex laboratory settings on May 29, 2020. In August 2020, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, provided funding and technical support to NOWDiagnostics under contract number 75A50120C00156 for the delivery of a high-quality serological test to detect the presence of antibodies against SARS-CoV-2. The test is designed for use across a variety of health care settings—from hospital emergency rooms to clinics—and ultimately, by consumers for at-home use.
The ADEXUSDx® COVID-19 Test is a rapid serology, self-contained assay that measures the presence of antibodies against SARS-CoV-2 and delivers lab-quality results in 15 minutes with no buffers, reagents, or additional equipment. The test requires only a drop of blood (either capillary blood from a simple fingerstick or 40 μL of venous whole blood, serum, or plasma) and has the potential to be deployed directly into homes and workplaces.
Reliable antibody tests will play a critical role in understanding the number of people who have been infected with COVID-19 and may be helpful in the development and administration of COVID-19 therapies and vaccines. Availability of POC/CLIA waived and over-the-counter (OTC) tests will allow individuals to be screened easily and quickly, yielding test results in minutes instead of days.
Upon receiving FDA authorization for emergency use, C19 Development, LLC, a wholly owned subsidiary of NOWDiagnostics, will begin offering the ADEXUSDx® COVID-19 Test for use in CLIA-waived facilities across a variety of health care settings—from pharmacies to clinics to hospital emergency rooms. Clinical trials for OTC test use are ongoing.
This project has been funded in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00156.
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NOWDiagnostics, Inc., based in Springdale, Arkansas, is a leader in innovative diagnostics testing. Its ADEXUSDx® product line 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 by days. For more information about NOWDiagnostics, visit 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 www.c19development.com. The ADEXUSDx® COVID-19 Test will be distributed by C19 Development, LLC, a wholly owned subsidiary of NOWDiagnostics. Laboratories may contact www.c19development.com/order to place an order.
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