NEW YORK – OraSure Technologies this week provided updates on its plan to submit a one-step rapid antigen test to detect SARS-CoV-2 to the US Food and Drug Administration for Emergency Use Authorization. The firm will file for prescription-use, self-test and professional use indications by the end of March, with an at-home self-test indication to follow.
With plans to expand its manufacturing capacities, OraSure said it will leverage its existing global relationships to supply the test worldwide for years to come.