OraSure Technologies’ Rapid Diagnostic OraQuick Ebola Rapid Antigen Test Receives the US FDA Marketing Approval for Detection of Ebola Virus Antigens

Shots:

  • The approval is based on multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak plus multiple analytical studies
  • Themarketing authorization for firstrapid diagnostic test for EVD is reviewed under De Novo premarket review pathway reflecting the ongoing collaboration between the US Government and test developers to gather additional data on EUA products
  • The OraQuick Ebola Rapid Antigen Test is a first rapid diagnostic test approved for EVD and has also received BT Device designation and can be used to support safe and dignified burials helping to reduce the risk of transmission during those burials

Click here to­ read full press release/ article | Ref: The US FDA | Image: OraSure Technologies