Ortho Awarded BARDA Contract to Accelerate Development of SARS-CoV-2 Antigen Test

Ortho Clinical Diagnostics (Raritan, NJ, USA) has been awarded USD 12,850,000 by the Biomedical Advanced Research and Development Authority (BARDA) to support the development of the company's SARS-CoV-2 antigen test and continued regulatory pathway support for its total and IgG antibody tests.

Ortho manufactures two SARS-CoV-2 antibody tests - total and IgG - which were granted Emergency Use Authorization by the US Food & Drug Administration in April. Ortho's total antibody test detects all COVID-19 related antibodies (IgA, IgM and IgG) and Ortho's COVID-19 IgG antibody test detects the IgG antibody, which appears in a patient's blood in the later phase of the infection and remains elevated even after recovery. The tests offer greater choice in tracking, surveillance and patient management. The test results also can help aid in determining who may be eligible to donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. Both of Ortho's tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus. The tests run on Ortho's high-throughput, fully automated analyzers including its flagship VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems.

With the new contract, Ortho has continued its collaboration with the BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, as part of the agency’s and federal government's ongoing COVID-19 medical countermeasure development efforts.

"Only highly specific tests authorized by the US Food and Drug Administration - like those manufactured by Ortho - should be trusted for use in any testing strategy, as their reliable and accurate results have enormous potential to improve disease surveillance, identify people whose blood may be used for vaccine development and convalescent plasma, and help scientists answer pressing questions about immunity," said Michael Iskra, Head of Commercial Excellence and Strategy, Ortho Clinical Diagnostics. "We believe that every test is a life and will continue to innovate to bring highly accurate, specific tests to market to help level this devastating pandemic."