Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today 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. “Because Every Test is a Life,™ we 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.
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. Ortho has over 5,600 Immunodiagnostic systems installed around the world, with more than 1,000 already installed in hospital and reference labs throughout the United States. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.
Ortho manufactures its antibody tests in Rochester, New York and Pencoed, UK and produces millions of tests per week.
Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. Ortho’s antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options.
This project has been funded 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. 75A50120P00103.
The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.