ITHACA, NY — Rheonix Inc. announced today (Apr. 30) that it has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for the Rheonix COVID-19TM MDx Assay. The fully automated test enables detection of SARS-CoV-2, the virus that causes COVID-19, directly from respiratory samples. The test is designed to operate on the Rheonix Encompass MDx® workstation, and will facilitate same-day test results for small and medium-throughput laboratories.
The Rheonix COVID-19 MDx Assay is a sample-to-answer test that requires no technician involvement after loading the samples onto the workstation. The system enables cost-effective on-site testing at distributed locations, thus allowing for more rapid decisions regarding isolation and treatment of infected patients. 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.
“Rapid diagnosis is critical in efforts to control the SARS-CoV-2 virus,” said Richard Montagna, PhD, FACB, senior vice president for scientific and clinical affairs, Rheonix. “We at Rheonix are grateful to the people on the front lines fighting the spread of the COVID-19 illness, and are proud to be able to support them with a rapid, accurate and automated tool to assist in their efforts.”
The Rheonix COVID-19 MDx Assay is processed on the fully automated Rheonix Encompass MDx workstation using proprietary Rheonix Encompass CARD® cartridge technology. The system requires minimal training to use, and can be quickly installed in critical locations of immediate need. It is ideally suited for use in low to medium-throughput labs, enabling same-day results for local and regional health networks, institutional facilities, and rural hospitals.
About Emergency Use Authorization Status:
The Rheonix COVID-19™ MDx Assay is an endpoint RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory samples from individuals who are suspected of COVID-19 by their healthcare provider. The Rheonix COVID-19 MDx Assay has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.