Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that it was recognized with MedTech’s 2020 Outstanding Contribution to the Bio/Med Industry Award for its diagnostic solutions to the COVID-19 pandemic. Ortho was the first company to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for both its high-throughput COVID-19 antibody test, which helps doctors and those surveilling the spread of the disease understand who has been infected by detecting key proteins (antibodies) in the blood, and antigen test, designed to detect active infection.
As early as February 2020, while most of the world was only beginning to grasp the potential scale and scope of the SARS-CoV-2 virus, Ortho scientists were already working to leverage the company’s 80-year legacy of pioneering life-impacting diagnostic testing advances. In just 19 days, Ortho went from concept to FDA-authorized use of the VITROS® COVID-19 Total Antibody Test. Less than two weeks later, Ortho received a second FDA EUA for its VITROS® COVID-19 IgG Antibody Test, which detects a serological test that detects the IgG antibody and offers 100% specificity, helping prevent false positives.
“Ortho’s work in developing COVID-19 antibody tests is not only a game-changer in the fight against the novel coronavirus, but is also a testament to Ortho’s ability to mobilize resources and expertise on a moment’s notice,” said Win Thurlow, MedTech’s Executive Director. “While many companies have performed extraordinary work this past year, Ortho’s achievement stands heads above the rest.”
“Ortho is proud to play a critical role in providing hospitals and laboratories worldwide with highly accurate COVID-19 solutions so that they can ensure their patients and communities receive fast, reliable results that lead to the best patient care,” said Warren Stone, President, Americas, Ortho Clinical Diagnostics. “We are honored to receive recognition from MedTech for our COVID-19 response. We were simply answering the call and leveraging our strong expertise in infectious disease to do what we do best, providing tests that deliver accurate, trusted results consistently.”
In addition to its antibody tests, Ortho’s high-volume coronavirus antigen test detects the virus that causes COVID-19. The VITROS® SARS-CoV-2 Antigen Test has utility for mass-scale testing and delivers same-day results to help hospitals and reference labs address testing backlogs, supply shortages, and delayed results. Ortho has begun shipping millions of units in Europe, where the test was awarded a CE Mark last year, and in the United States, under an Emergency Use Notification in the late fall. The test received FDA EUA on January 11, 2021.
MedTech is New York’s trade association for the bio/med industry—an innovative coalition of pharmaceutical, medical technology, and life sciences companies, research and academic institutions, suppliers, and service providers. With its Global Center of Excellence for R&D located in Rochester, New York, Ortho is proudly a sustaining member of MedTech.
The association presented the award to Ortho at their 2020 Outstanding Contribution to the Bio/Med Industry Honors ceremony, held virtually on Thursday, January 14, 2021. The association will honor nine New York companies and institutions that have made outstanding contributions to improving health and responding to the coronavirus pandemic.
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