Tag Archives: OraSure Technologies

November 2019—The FDA granted in October marketing authorization of the OraQuick Ebola Rapid Antigen Test to OraSure Technologies. The test is intended for use in patients suspected of and with signs or symptoms consistent with Ebola virus disease and when the patient meets the CDC’s Ebola virus epidemiological criteria, such as history of residence in or travel to a geographic region with active EVD transmission at the time of travel.

OraSure Technologies received FDA Emergency Use Authorization for its OraQuick Ebola Rapid Antigen Test, which is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors.

February 2014—OraSure Technologies has reached an agreement with Thermo Fisher Scientific to develop and supply up to 12 homogenous, fully automated oral fluid drugs-of-abuse assays to be used with OraSure’s new Intercept oral fluid specimen collection device. OraSure will have the right to purchase and resell the assays in the U.S. and certain foreign countries, subject to receipt of applicable regulatory approvals.