Rheonix announced that the U.S. Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19 MDx Assay to allow the use of saliva as an approved sample type, according to a press release.
The fully automated assay was initially authorized for use under EUA on April 29, 2020.
The ability to test saliva samples for the presence of SARS-CoV-2, the virus that causes COVID-19, simplifies the sample-collection process and streamlines the testing workflow, while reducing the exposure of medical personnel to potentially infected individuals, Rheonix said.
For patients, this less invasive sample collection method is a welcome alternative to nasopharyngeal (NP) swabs, the most prevalent sample type. In addition, use of saliva as a sample type helps to ease critical supply chain issues by eliminating the need for specialized swab or collection devices, the company said.
The Rheonix COVID-19 MDx Assay is processed on the fully automated Rheonix Encompass MDx workstation using proprietary Rheonix CARD cartridge technology. The system requires minimal training to use and provides same-day results.
