ITHACA, NY — Rheonix Inc. announced Dec. 7 that the United States Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19™ MDx Assay and now allows the use of saliva as an approved sample type. The fully automated sample-to-answer assay was initially authorized for use on a range of respiratory specimens 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. 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.
“We’d like to thank our colleagues at the Cayuga Medical Center in Ithaca, New York, and Catholic Health System in Buffalo, New York, for their wonderful help in validating the use of saliva,” said Richard Montagna, PhD, FACB, senior vice president for scientific and clinical affairs at Rheonix. “Our customers are excited about the addition of this sample type, which will help them conserve precious laboratory resources. We are continuing to expand our COVID-19 tests to help address their ongoing COVID-19 testing challenges.”
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 can be quickly installed in critical locations of immediate need. It provides same-day results and is highly scalable, enabling laboratories to move from outsourcing their COVID-19 testing to providing same- or next-day test results for their communities or regions. Rheonix has supported customers’ expanding testing needs by significantly scaling its manufacturing capacity, committing reagent availability to support its customers’ 24/7 testing requirements.