Ortho Awarded Contract to Accelerate Antigen Test Development

Ortho Clinical Diagnostics announced its continued collaboration with 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, in a new contract as part of BARDA's and the federal government's ongoing COVID-19 medical countermeasure development efforts.

BARDA awarded Ortho $12,850,000 to support the development of the company's SARS-CoV-2 antigen test, a diagnostic test designed for the rapid detection of the virus that causes COVID-19, and continued regulatory pathway support for Ortho's total and IgG antibody tests. Ortho manufactures two SARS-CoV-2 antibody tests—total and IgG—which were granted Emergency Use Authorization by the U.S. Food & Drug Administration in April.

"Only highly specific tests authorized by the U.S. 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."

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. As noted on the U.S. Food and Drug Administration's website, 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.