OraSure Technologies has been awarded a $629,217 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to develop an Enzyme-Linked Immunosorbent Assay (ELISA) for the detection of human anti-SARS-CoV-2 antibodies in oral fluid specimens. Currently, there are no oral fluid-based COVID antibody tests available with automated assays.
This support from BARDA will help OraSure—which got its start at the Ben Franklin Technology Center at Lehigh University in the 1980s—complete development and file for FDA Emergency Use Authorization. EUA would allow the laboratory-based microplate antibody test for oral fluid samples to enter into the U.S. market. 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.
“The coronavirus pandemic is complicated and fast moving. It will take a variety of tests to get it under control,” says OraSure President and CEO Stephen S. Tang, a Lehigh chemical engineering alumnus. “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."
This oral fluid ELISA is expected to increase laboratory COVID-19 antibody testing capacity and could play a vital role in detecting coronavirus antibodies which can be detected within one to three weeks after the onset of symptoms, according to a media release. The company says such tests could help identify people who had past COVID-19 infections, even without symptoms, potentially allowing them to safely return to work or other activities if data show antibody development with past infection translates to future immunity. In addition, OraSure says this test could help meet an urgent need to screen the population, especially health care workers, for past asymptomatic infection and potential immunity against COVID-19.
Assuming product development and clinical testing are successful, OraSure is targeting initial product sales this summer with EUA following shortly thereafter.
Read the full press release on OraSure's website.
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