November 3, 2020 – OraSure Technologies, Inc. (Bethlehem, PA) announced that its DNA Genotek subsidiary received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of the ORAcollect·RNA (OR/ORE-100) saliva collection device for the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA.
This is the second FDA EUA that DNA Genotek has received for its saliva collection devices.
Like the EUA DNA Genotek recently obtained for OMNIgene·ORAL (OM/OME-505), this EUA allows for the unsupervised use of the device at-home or in a healthcare setting when used as a component of an authorized or cleared self-collection kit. This means it can be part of a kit that is authorized under its own EUA for use by an individual to collect saliva specimens at home.
The ORAcollect·RNA collection device is an important component of molecular/PCR tests as laboratories are able to use it as the saliva sample collection method for their COVID-19 tests, OraSure says.
In addition to molecular sample collection devices for lab-based molecular/PCR COVID-19 testing from its DNA Genotek subsidiary, OraSure is also developing a lab-based oral fluid SARS-CoV-2 antibody test, and a rapid antigen self-test for COVID-19.