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 |

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

Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.