Ortho Clinical Diagnostics announced that it received a nearly $12.9 million award from BARDA to support the development of its COVID-19 antigen test.
Raritan, N.J.-based Ortho Clinical Diagnostics and the Biomedical Advanced Research and Development Authority (BARDA) are working together under a new contract as part of the government’s ongoing COVID-19 medical countermeasure development efforts, according to a news release.
BARDA awarded Ortho $12.85 million in support of its SARS-CoV-2 antigen test for the rapid detection of the virus causing COVID-19. That funding will also go toward the pursuit of regulatory clearance for Ortho’s total and IgG antibody tests that were granted FDA emergency use authorization (EUA) in April.
Ortho’s total antibody test is designed to detect all COVID-19-related antibodies, while the IgG test detects the IgG antibody which appears in the later stages of infection and remains elevated even after recovery. Both tests run on Ortho’s high-throughput, fully-automated Vitros analyzer systems, of which the company has over 5,600 installed around the world, with more than 1,000 installed in the U.S. The company said it is manufacturing millions of tests per week out of its Rochester, N.Y., and Pencoed, Wales facilities.
“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,” Ortho head of commercial excellence & strategy Michael Iskra said in the release. “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.”