On Mar. 30, 2021, OraSure Technologies announced that it had submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its COVID-19 rapid antigen test for both Prescription Home Use, and Professional Use in point of care (POC) settings.

These lateral flow, rapid diagnostic tests are designed to detect active COVID-19 infection with a simple, easy-to-use workflow, using samples self-collected from the lower nostrils. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution. No instrumentation, batteries, smart phone or laboratory analysis is needed to read the result, which appears on the test stick a short time later.

Subject to receipt of Emergency Use Authorization, the Company intends to market a COVID-19 Prescription Home Self-Test and a Professional Test for use in POC settings. With a simple design and straightforward workflow, OraSure’s tests are well suited for use by individuals at home, as well as by health care providers, employers, pharmacies, universities, and deployment into underserved communities when prescribed by a healthcare provider.