OraSure’s DNA Genotek Subsidiary Receives FDA Emergency Use Authorization for its ORAcollect®·RNA Saliva Collection Device for SARS CoV-2

OraSure Technologies announced its DNA Genotek subsidiary has 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.

“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.”

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.

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.

The ORAcollect·RNA and OMNIgene·ORAL sample collection devices have not been FDA cleared or approved; the devices have been authorized by FDA under an EUA. The ORAcollect·RNA and OMNIgene·ORAL sample collection devices have been authorized only to collect, stabilize, and maintain during transport, saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA), not for any other viruses or pathogens; and the ORAcollect·RNA and OMNIgene·ORAL sample collection devices are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in medical devices during the COVID-19 outbreak under Section564(b)(1) of the Federal Food, Drug, and Cosmetic Act,21U.S.C. §360bbb-3(b), unless the authorization is terminated or revoked sooner.

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