July 12, 2021 8:27 AM 1 min read

Ortho Clinical Diagnostics' COVID-19 Antibody Test Gets FDA Emergency Use Approval

by Vandana Singh Benzinga Editor
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  • The FDA has granted Emergency Use Authorization (EUA) to Ortho Clinical Diagnostics' OCDX VITROS Anti-SARS-CoV-2 IgG Quantitative Test.
  • The company says it the first quantitative COVID-19 IgG antibody test to receive a EUA nod.
  • Ortho's new quantitative COVID-19 IgG antibody test targets the S1 spike protein and is intended for use in identifying individuals with an adaptive immune response to SARS-CoV-2. 
  • The test offers 100% specificity and excellent sensitivity, the company said in the press release.
  • The new test is calibrated to the World Health Organization International Standard for anti-SARS-CoV-2 IgG antibodies. 
  • Price Action: OCDX shares closed at $21.32 on Friday.
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