Rheonix assay receives expanded FDA EUA for saliva samples

Dec. 9, 2020

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. 

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