Rochester company’s antibody test for COVID-19 receives authorization from FDA


ROCHESTER, N.Y. (WROC) — The U.S. Food and Drug Administration has granted emergency use authorization to Ortho Clinical Diagnostic’s total antibody test for COVID-19.

The tests will help determine who can be permitted to go back to work by aiding in the identification of currently infected or previously exposed individuals who may have developed immunity.

According to Ortho, the test can also help screen plasma donations for convalescent plasma therapy, which helps critically ill patients fight the virus, help medical professionals and epidemiologists better understand the spread of the disease, and can aid in vaccine development efforts.

“When you see the antibodies in your system and you no longer have the virus at some point, now you can become a plasma donor. You antibodies, because now you beat the disease could end up saving someone else’s life,” Ortho Clinical Diagnostics Chief Innovation Officer Dr. Chockalingam Palaniappan said in an interview with our sister station News 8 WROC earlier in April when the company was still waiting for approval.

“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 the 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.”

Chris Smith, chief executive officer at Ortho Clinical Diagnostics said in a statement. According to the company, a limited quantity of tests kits have already been shipped to areas of highest priority. 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.

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