Avalon GloboCare Corp (NASDAQ:AVCO) and Adial Pharmaceuticals Inc (NASDAQ:ADIL) announced Thursday the formation of a strategic collaboration for the global distribution of coronavirus (COVID-19) point-of-care antibody rapid test devices.
The Assure/FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) POC test for COVID-19 using fingerstick blood samples approved by the US Food and Drug Administration (FDA).
The FDA has issued an emergency use authorization (EUA) for the test device as well as for the Assure/EcoStep COVID-19 IgG/IgM Rapid Test Device.
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Under the agreement, Adial has granted Avalon non-exclusive, sub-distribution rights worldwide for both tests, according to a statement.
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 Devices are lateral flow assay, 10-minute POC 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.
"We believe there is significant market potential for these differentiated test kits, as these tests are able to detect IgG antibodies at a 98.6% accuracy and IgM antibodies at a 92.9% accuracy and provide results within 10 minutes," said Avalon CEO Dr David Jin in a statement. "Our goal is to leverage our international distribution network and channel partners to bring the product to market globally."
William Stilley, CEO of Adial, noted that Avalon has an established global distribution network that will facilitate further sales of the COVID-19 test devices worldwide.
“The rapid proliferation of COVID-19 around the world has driven demand for SARS-CoV-2 detection, and a widespread need for rapid antibody testing,” said Stilley. “We look forward to working with Avalon in order to help meet the global demand for rapid result COVID-19 serology testing."
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