OraSure Resubmits EUA Applications for ELISA COVID-19 Antibody Test

by Vandana Singh, Benzinga Editor

May 26, 2021 9:21 AM | 1 min read

OraSure Technologies Inc OSUR has resubmitted two separate Emergency Use Authorization (EUA) applications for its SARS-CoV-2 Antibody ELISA and the oral specimen collection device.
ELISA is intended to qualitatively detect total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device.
Last year in December, the FDA requested additional information as part of its review of its EUA for the company's laboratory-based oral fluid Covid-19 antibody test.
According to the SEC filing, the company has completed the necessary studies, collected the requested data, and, on May 21, submitted applications for the separate EUAs as requested by the FDA.
Price Action: OSUR shares are up 5.9% at $9.89 during the premarket session on the last check Wednesday.

Posted In: Biotech News Health Care Small Cap FDA General Briefs Covid-19 COVID-19 Vaccine

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