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Ortho Clinical Diagnostics Nabs $12.9M BARDA Award for SARS-CoV-2 Antigen, Antibody Tests

NEW YORK ─ The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) on Monday announced that it has awarded almost $12.9 million to Ortho Clinical Diagnostics to develop a high-throughput, automated COVID-19 antigen test and to further develop two of its SARS-CoV-2 antibody tests currently authorized for emergency use.

Ortho Clinical is developing the Vitros SARS-CoV-2 Ag (Antigen) test for the rapid qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swabs. The different types of antibody tests provide choices in tracking, surveillance, and overall patient management, BARDA said in a statement. Both antibody tests can help healthcare workers assess whether patients have been infected, including without showing symptoms, and have developed antibodies to the SARS-CoV-2 virus, BARDA added.

In June, the Raritan, New Jersey-based company announced that it had received a $678,000 award from BARDA to support the development of a total antibody test to detect IgA, IgM, and IgG antibodies to SARS-CoV-2, and to develop a separate test for IgG antibodies that remain elevated after a patient recovers from COVID-19. The new project expands on that earlier award.

The antigen and antibody tests run on Ortho Clinical’s high-throughput, fully-automated Vitros systems, including the Vitros XT 7600 Integrated System, the Vitros 3600 Immunodiagnostic System, the Vitros 5600 Integrated System, and the Vitros ECi/ECiQ Immunodiagnostic Systems.

Ortho Clinical received US Food and Drug Administration Emergency Use Authorization for the total antibody and IgG antibody tests in April.