March 31, 2021 – OraSure Technologies, Inc. (Bethlehem, PA) announced it has 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 EUA, the company intends to market a COVID-19 Prescription Home Self-Test and a Professional Test for use in POC settings.
OraSure says its tests are well suited for use by individuals at home, as well as by healthcare providers, employers, pharmacies, universities, and deployment into underserved communities when prescribed by a healthcare provider.
OraSure has started manufacturing the COVID-19 rapid antigen test in parallel with EUA submission. The company says it has well-established manufacturing capabilities, having produced over 80 million rapid HIV, HCV and Ebola tests.
OraSure is in the midst of a manufacturing capacity expansion that will bring annual capacity for its rapid tests from 55 million tests at the end of Q1 to 70 million tests beginning in Q3 2021, and further to 120 million units per year by Q2 2022. Included in these numbers are approximately 17 million of the company’s existing tests for HIV, HCV and Ebola.