OraSure Technologies has officially cut the ribbon on Opus Way, its new expanded facility in Bethlehem Township, which was constructed with the help of $109 million from the U.S. Department of Defense (DOD) to ramp up production of InteliSwab COVID-19 rapid tests as part of the nation’s pandemic preparedness plan. 

OraSure Technologies of Bethlehem has announced that its rapid COVID-19 test, InteliSwab, has been authorized by the FDA for use in children ages 2 to 14.

The U.S. Food & Drug Administration has amended its Emergency Use Authorization of OraSure’s InteliSwab COVID-19 rapid test. The Bethlehem diagnostic test manufacturer said the EUA now only requires one test for users who are presenting symptoms of COVID-19. 

OraSure Technologies Inc. has been awarded a $109 million contract from the U.S. Department of Defense to build additional manufacturing capacity for its InteliSwab COVID-19 rapid tests as part of the nation’s pandemic readiness plan. 

Just days after announcing that it had received a $205 million federal contract to provide COVID-19 InteliSwab tests, Bethlehem’s OraSure said the Biomedical Advanced Research Development Authority (BARDA) will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and CLIA waiver for their COVID-19 rapid test, InteliSwab, from the Food & Drug Administration. 

It’s the news Bethlehem’s OraSure Technologies Inc. has been waiting for. It announced today that it has received three Emergency Use Authorizations from the Federal Drug Administration for its COVID-19 rapid antigen tests.