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

By LabMedica International staff writers
Posted on 04 Nov 2020
OraSure Technologies, Inc.’s (Bethlehem, PA, USA) subsidiary, DNA Genotek, has received Emergency Use Authorization (EUA) from the US 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.

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.

Image: The ORAcollect·RNA collection device (Photo courtesy of OraSure Technologies, Inc.)
Image: The ORAcollect·RNA collection device (Photo courtesy of OraSure Technologies, Inc.)

“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.”




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