ORAcollect RNA Saliva Collection Device for SARS CoV-2 Granted FDA Emergency Use Authorization

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. This is the second FDA EUA received by DNA Genotek for its saliva collection devices. Similar to the EUA recently obtained by DNA Genotek for its OMNIgene·ORAL (OM/OME-505), the latest 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.

“Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout the duration of the COVID-19 pandemic,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “This second EUA gives our customers additional non-invasive options for SARS CoV-2 sample collection. Saliva sample collection is quick, painless, non-invasive and requires less human contact both minimizing the need for PPE and reducing exposure to potentially infected patients.”