OraSure receives $630K to help develop oral test for coronavirus antibody

Bethlehem’s OraSure Technologies Inc. received nearly $630,000 to help develop an oral test for coronavirus antibodies.

The funds come from a contract with the federal Biomedical Advanced Research and Development Authority to develop an enzyme-linked immunosorbent Assay, or ELISA, which can be used for the detection of human anti-SARS-CoV-2 antibodies in oral fluid specimens. There currently are no oral fluid-based COVID antibody tests of the sort. The product is expected to increase laboratory COVID-19 antibody testing capacity.

OraSure said the support from BARDA will help it complete development of the ELISA and file for Emergency Use Authorization from the Food & Drug Administration to enter the U.S market.

The test could help identify people who had a COVID-19 infection, even without symptoms, potentially allowing them to safely return to work or other activities if data show antibody development translates to future immunity.

“The coronavirus pandemic is complicated and fast moving. It will take a variety of tests to get it under control,” said OraSure President and CEO Stephen S. Tang in a press release. “Understanding who is contagious and who has potentially protective antibodies will be crucial as the country continues reopening the economy and returning to everyday life. We believe that the combination of the OraSure antibody and antigen tests along with our sample collection capabilities, can give people insight into their COVID-19 status across the infection spectrum. We are proud to bring our proven expertise with oral fluid collection and testing to this global pandemic.”

This is the second COVID-related test for which the company has received BARDA funding. The first, a rapid, antigen in-home oral fluid self-test, was announced in April.