Bethlehem-based OraSure Technologies has been awarded a $710,310 federal contract to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples.
The company, which was minted at the Ben Franklin Technology Center at Lehigh University in 1987 and is currently led by chemical engineering alum Stephen S. Tang ’85G ’88 PhD, will receive support from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS). The grant will enable OraSure to file for FDA Emergency Use Authorization (EUA) allowing for an in-home self-test to debut into the U.S. market.
“Lives and global economies are at stake. It’s crucial that we understand just how many people are infected with SARS-coronavirus,” says Tang, OraSure’s president and chief executive officer. “In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our healthcare systems and labs some much-needed breathing room. We believe that the development of an easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates. We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic.”
Built on OraSure’s OraQuick platform, the rapid test would allow for in-home self-testing by lay users as well as by medical professionals. OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes. No instrumentation or trained personnel would be needed to administer the test or to read the results.
OraSure has a well-documented history of success with in-home infectious disease testing; the company’s oral fluid self-test for HIV has been used to diagnose millions of people around the world and connect them to life-saving care.
OraSure envisions a rapid development cycle of approximately 4-6 months prior to seeking Emergency Use Authorization (EUA).
Read the full press release on OraSure’s website.
