New COVID-19 test developed in Rochester receives FDA approval

New COVID-19 test developed in Rochester receives FDA approval

The U.S. Food and Drug Administration on Tuesday said it had granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody test for COVID-19. The test is one of the first high-throughput, automated COVID-19 antibody tests to be granted Emergency Use Authorization.

High-throughput instruments can output a large number of test results in a short period of time. When running infectious disease tests such as the COVID-19 tests, Ortho’s instruments can process up to 150 tests per hour.

“The COVID-19 pandemic continues to impact individuals, families and communities around the world,” said Chris Smith, Ortho Clinical Diagnostics CEO. “Ortho is proud to be working toward large-scale solutions that will help people return to work, reducing the strain on both employees and the economy as a whole. Our focus on improving patients’ lives through diagnostics led us to rapidly develop this test, providing one of the key resources needed for diagnosing and treating COVID-19. We remain committed to helping laboratories deliver fast, accurate, reliable results to healthcare professionals, patients and the researchers developing the long-term, sustainable management of this disease.”

A limited quantity of test kits already have been shipped to high priority areas. Ortho will be in full production in the coming weeks and plans to manufacture several million SARS-CoV-2 antibody tests over the next month, with rapid production expansion following thereafter.

The test was developed at Ortho’s Global Center of Excellence for R&D in Rochester and can be run on the company’s flagship laboratory analyzer, the VITROS T 7600 Integration System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and soon on the VITROS ECi/ECiQ Immunodiagnostic Systems, which are installed in more than 1,000 hospitals and labs in the U.S.

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