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US FDA issues EUA to Adial Pharma’s Assure/FaStep COVID-19 IgG/IgM rapid test device for using with fingerstick blood samples

Charlottesville, Virginia
Thursday, October 1, 2020, 17:00 Hrs  [IST]

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) have issued an emergency use authorization (EUA) for the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device. This marks the first FDA EUA for a serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw.

As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The FaStep COVID-19 IgG/IgM Rapid Test Device was initially authorized for emergency use in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, but as with all competing rapid COVID-19 test kits, was not yet authorized for fingerstick blood sample use.

Adial has commenced sales of the FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through the iRemedy Healthcare Companies, Inc. (iRemedy) network and ecommerce platform. See here. Antibody test kits distributed by Adial are lateral flow assay, 10-minute, ‘instant' point-of-care test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in fingerstick whole blood, venous whole blood, serum, and plasma. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

William Stilley, chief executive officer of Adial Pharmaceuticals, commented, “The issuance of the EUA for the first point-of-care antibody test for COVID-19 in the US using fingerstick blood samples is expected to provide an important competitive advantage, which should support more widespread adoption of the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device as a fast, convenient and reliable method for COVID-19 serology testing. We see a market demand for these instant and efficient antibody tests to help combat the international COVID-19 pandemic with the addressable global COVID-19 rapid test kits market expected to reach US$ 3.52 billion by the end of 2020.”


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