OraSure’s At-Home Saliva Sample Collection System Authorized for Emergency Use

The FDA has granted Emergency Use Authorization (EUA) for OraSure Technologies’ OMNIgene ORAL saliva collection and stabilization device.

The EUA allows the device to be used in healthcare settings or by patients at home to collect and ship saliva samples for approved COVID-19 test kits. The collection system was previously cleared in the EU.

At-home collection of samples reduces the risk of virus transmission as the test does not require an in-person visit with a clinician.