Orasure Announces FDA Emergency Use Authorization for Ebola Rapid Diagnostic Test

OraSure Technologies, Inc.

, a leader in point of care diagnostic tests and specimen collection devices, announced today that it has received a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its OraQuick® Ebola Rapid Antigen Test for use with fingerstick and venous whole blood. This test has not been cleared or approved by FDA. This test has been authorized by FDA under an EUA for use by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). The OraQuick® Ebola Rapid Antigen Test utilizes the OraQuick technology platform which is the same proven technology used in the Company's rapid HIV and HCV antibody test kits. This authorization allows the use of the OraQuick® Ebola Rapid Antigen Test for the duration of the U.S. Secretary of the Department of Health and Human Services' (HHS) August 5, 2014 declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Ebola virus, unless the EUA is terminated or revoked sooner. The OraQuick® Ebola Rapid Antigen Test is designed to detect viral antigens in fingerstick and venous