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

by Vandana Singh, Benzinga Editor

July 12, 2021 8:27 AM | 1 min read | Make a Comment

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.

Posted In: Biotech News Health Care FDA General Briefs

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