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FDA Expands EUA for Rheonix’s COVID-19 Assay

December 9, 2020

The FDA has broadened the Emergency Use Authorization (EUA) it granted for Rheonix’s COVID-19 MDx Assay, allowing saliva samples to be used with the test.

Rheonix’s sample-to-answer assay was already cleared under emergency use for samples from nasopharyngeal swabs, throat swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid.

“The ability to test saliva samples for the presence of SARS-CoV-2 … 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 swabs.”

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