Todos Medical Ltd (OTCQB:TOMDF) announced Thursday a distribution agreement with Adial Pharmaceuticals Inc (NASDAQ:ADIL) to market the Assure/FaStep and EcoStep point-of-care (POC) COVID-19 antibody tests.
The Assure/FaStep test received the first US Food and Drug Administration Emergency Use Authorization (EUA) for a serology (antibody) POC test for COVID-19 using fingerstick blood samples -- versus current 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 tests in POC settings, including doctors’ offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional.
The tests were 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, the tests were not yet authorized for fingerstick blood sample use.
“Adding a rapid, fingerstick antibody test that has received Emergency Use Authorization from the FDA as a point-of-care test to our portfolio is expected to dramatically increase the settings in which we are able to provide COVID-19 antibody testing for our growing list of clients,” said Todos CEO Gerald Commissiong in a statement.
“We have now established a strong network of high-complexity CLIA lab clients who are implementing our PCR solutions, and we will now add rapid tests to our emerging pharmacy and skilled nursing facility point-of-care sales channel. We believe there is significant synergy in selling complementary COVID-19 tests in the marketplace.”
Adial CEO William Stilley said the agreement will add a “new category of clients” for the company.
“Our agreement was entered into following multiple sales of these Tests to Todos and therefore, we see a market demand from Todos’ clients for these instant and efficient antibody tests to help combat the international COVID-19 pandemic,” Stilley said.
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