Adial Pharmaceuticals Inc. (NASDAQ:ADIL) Receive EUA from the FDA For COVID-19 IgG/IgM Rapid Test Devices

Adial Pharmaceuticals Inc. (NASDAQ:ADIL) has announced receipt of an initial purchase order for 10,000 Assure/FaStep® COVID-19 IgG/IgM Rapid Test Devices from a technology company based in California.

Adial receives EUA for COVID-19 IgG/IgM Rapid Test Devices

The order comes at the back of the FDA issuing emergency use authorization (EUA) for FaStep® COVID-19 IgG/IgM Rapid Test Device. This will be the first FDA EUA for a serology point of care test devices for COVID-19 that uses fingerstick blood samples compared with already approved tests that utilize plasma, serum, or venous blood draw.

Following the FDA’s EUA, now fingerstick blood samples can be used with the COVID-19 IgG/IgM Rapid Test Device for testing in POC settings that include hospitals, doctors’ offices emergency rooms, urgent care centers as well as other locations having licensed healthcare professional. The device was initially authorized in July 2020in to identify individuals with SARS-CoV-2 antibodies, an indication of previous or recent COVID-19 infection.

Adial receives first order for COVID-19 IgG/IgM Rapid Test Devices

The company has already commenced sales of the test kits to hospitals and healthcare providers via the iRemedy Healthcare Companies Inc. network and eCommerce marketplace. William Stilley, the CEO of the company, confirmed that among the orders they had received for the COVID-19 IgG/IgM Rapid Test Devices was from a California-based company that ordered 10,000 kits. Stilley said that the availability of a rapid and convenient COVID-19 testing is vital in assessing the virus’s prevalence to reduce the spread of the virus as the US continues to reopen. He said that the issuance of the EUA for the first POC COVID-19 test using fingerstick blood samples in the US is a huge milestone that will result in enhanced demand for COVID-19 IgG/IgM Rapid Test Devices.

Adial’s test devices are lateral flow assay, 10 minute instant POC test devices that qualitatively detect SARS-CoV-2 specific IgM and IgG antibodies in whole blood, serum, plasma, and venous whole blood. When testing, the blood specimen from the subject is put in a test cassette and will react with antigen-coated particles in the cassette.