Client & Alumni News

OraSure Submits COVID-19 Rapid Home Self-Test to FDA for Emergency Use Authorization

BFTP alumnus client OraSure Technologies, Inc. (NASDAQ: OSUR) announced that 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.

“We believe our rapid antigen tests will be well received in the market thanks to their simplicity and ease of use. We also have the proven experience and capabilities to manufacture at scale to meet demand. With the race between vaccines and variants ongoing, testing will continue to play a crucial role in reopening workplaces, schools and other places where people gather,” said Stephen Tang, Ph.D., President and CEO of OraSure Technologies. “I’m delighted that we were able to accelerate the submission of the Prescription Home Self-Test. At-home testing will make it easier for individuals to safely and quickly know if they are infectious, and self-isolate to minimize transmission.” Via Lehigh Valley Business.