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. 

OraSure Technologies in Bethlehem has secured a $205 million contract from the Defense Logistics Agency to supply its InteliSwab over-the-counter COVID-19 test kits as part of the national pandemic response. 

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.

As the company quickly pivoted to address the COVID-19 pandemic, Bethlehem’s OraSure Technologies Inc. exited 2020 a stronger company with an 11% growth in sales -- $50 million of which was in COVID-19-related testing equipment alone.

Bethlehem’s OraSure has gotten the approval it needs for its saliva-based sample collection device.

OraSure Technologies has developed a saliva collection device that’s been included in an FDA emergency authorization grant to a Syracuse medical diagnostic development company for COVID-19 lab testing.

Tang and his team at OraSure are facing their biggest challenge yet, creating a test that will accurately and quickly determine if a person has been exposed to the COVID-19 virus.

OraSure Technologies of Bethlehem said it expects to launch its COVID-19 rapid antigen in-home self-test by the fourth quarter of this year.