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anti-body test approved by FDA
RARITAN, N.J., April 3, 2020 /PRNewswire/ -- Aligned with its mission to improve and save lives with diagnostics, Ortho Clinical Diagnostics today announced it is launching to market its SARS-CoV-2 (COVID-19/coronavirus) antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Testing kits are expected to be available in a few weeks.
Ortho followed the guidelines established by the U.S. Food and Drug Administration's (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
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Given the incredible demand for information to change the tide of this pandemic, Ortho felt it was necessary to market as quickly as possible with a notification to the FDA," said Smith. "We are working to make our antibody test kit available to the areas with the greatest need first and will be working in parallel to both increase our test kit production and follow additional regulatory pathways to secure further approvals."