Rheonix announced that it has received expanded FDA emergency use authorization for its Rheonix COVID-19 MDx assay.
Ithaca, N.Y.-based Rheonix’s expanded authorization allows the use of saliva as an approved sample type after the assay was initially authorized for use on a range of respiratory specimens in April, according to a news release.
The Rheonix COVID-19 MDx assay is processed on the fully automated Rheonix Encompass MDx workstation using the company’s proprietary Rheonix CARD cartridge technology.
Results are provided within the same day of analysis and the system is highly scalable, Rheonix said, allowing for laboratories to provide same-day or next-day results without having to outsource samples.
“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,” Rheonix senior VP for scientific and clinical affairs Richard Montagna said in the release. “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.”