Rheonix announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a fully automated molecular test to detect SARS-CoV-2 directly from respiratory samples, according to a news release from the company.
The Rheonix COVID-19 MDx Assay is designed to operate on the Rheonix Encompass MDx workstation, facilitating same-day test results. The system is ideally suited for small and medium-throughput laboratories, the company said.
The Rheonix COVID-19 MDx Assay is a sample-to-answer test that requires no technician involvement after loading the samples onto the workstation, allowing onsite testing at distributed locations.
Rheonix has begun shipment of the workstation and test kits to high-need local and regional hospital laboratories to enable them to begin testing immediately.
