OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices and microbiome laboratory and analytical services, today announced it has been awarded a $629,217 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at 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 complete development and file for FDA Emergency Use Authorization (EUA), which 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,” said OraSure President and Chief Executive Officer Stephen S. Tang, Ph.D. “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 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. 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, 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.

With this test, human antibodies found in oral fluid would be collected via a wand and pad and eluted into the OraSure® oral fluid specimen collection device buffer for storage and transport, and later dispensed onto the ELISA microplate for testing in a laboratory. The assay, in conjunction with the collection device, would be utilized under FDA’s Emergency Use Authorization (EUA).

Under the initial EUA, if obtained, the collection device would be available for specimen collection in a physician’s office, a lab or a testing facility.

The EUA subsequently could be amended to permit an in-home or self-collection option. Being able to collect samples at home would promote social distancing and minimize healthcare workers’ exposure to patients who potentially are infected.

Oral fluid testing also provides an easier and pain-free sample collection method as compared to nasopharyngeal or oropharyngeal samples or serology antibody tests which require a blood draw.

Assuming product development and clinical testing are successful, OraSure is targeting initial product sales this summer with Emergency Use Authorization (EUA) following shortly thereafter.

In April, the company announced the first COVID-19 test in development with funding from BARDA. That test is a pan-SARS-coronavirus rapid antigen in-home self-test that uses oral fluid samples and provides results in-home or at the point of collection. OraSure is also working with laboratories and researchers to demonstrate the effectiveness of certain of its molecular sample collection technologies for coronavirus testing. To date, three of its sample collection devices have been incorporated into assays receiving FDA EUA, illustrating the versatility of its products for COVID-19 detection. Strong data on the usability of OraSure’s molecular collection products support this usage of its products for COVID-19 related applications.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00122.

Source: Company Press Release